BEUDAMED
    Product Code: DQA FDA class 2 21 CFR 870.2700

    Oximeter

    Cardiovascular

    The Oximeter is a non-invasive diagnostic device that measures blood oxygen saturation by detecting the differential absorption of light by oxygenated and deoxygenated hemoglobin, widely used in clinical monitoring of patients' respiratory and cardiovascular status. It is a Class 2 device requiring 510(k) premarket clearance to demonstrate substantial equivalence to a predicate device. The product code is DQA, regulated under 21 CFR 870.2700, within the Cardiovascular medical specialty. No special regulatory flags apply.

    View on FDA
    510(k)s
    712
    FEI Numbers
    403
    Registration Numbers
    403
    Unique Applicants
    290
    Years Active
    47

    Basic Information

    Product Code
    DQA
    Device Class
    FDA class 2
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 712 510(k) clearances via K numbers.

    K Number Device Name
    K241086 Avidhrt Sense SpO2
    K242876 Pulse Oximeter ( PO2, PO2A, PO2B)
    K233963 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
    K243086 Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
    K242455 AViTA Pulse Oximeter (SP62B)
    K242580 Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
    K233956 Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
    K243049 Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
    K241090 Evie Med Ring
    K232520 Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH
    K240092 Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)
    K234110 Belun Ring BLR-200 (BLR-200)
    K240808 Pulse Oximeter (WS20A)
    K233827 OxiWear
    K231979 Mecun SpO2 sensor
    K232989 Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E)
    K232975 Pulse Oximeter (MD300C228)
    K240305 ANNE Limb
    K223399 AViTA Pulse Oximeter
    K232495 Sempulse Halo Vital Signs Monitor
    K231288 Vyvo
    K230277 Pulse Oximeter(Model OHT60,OXH78)
    K231531 Pediarity™
    K223721 Masimo Stork
    K230587 Wrist Pulse Oximeter
    K231243 Finger Clip Pulse Oximeter
    K232389 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue
    K221361 circul™ pro Ring
    K230172 Pulse Oximeter
    K211143 Pulse Oximeter
    K222597 BabySat 3
    K221798 Finger Pulse Oximeter, Model: X1906P
    K213676 Masimo Rad-G with Temperature
    K220101 Pulse Oximeter
    K213431 Handheld Pulse Oximeter
    K222010 Biobeat Platform-2 and BB-613WP Patch
    K213430 Fingertip Pulse Oximeter
    K222213 Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
    K213984 Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
    K221282 Empatica Health Monitoring Platform
    K220351 Polso Watch
    K203812 Oxyfit Pulse Oximeter
    K221979 Pulse Oximeter (Model C101A2, C101B1, C101A3)
    K212385 YUWELL Finger Pulse Oximeter
    K221953 Masimo CARESCAPE SpO2 – Masimo with SpHb
    K212665 Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
    K203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
    K213515 WesperO2
    K212752 Med-link Pulse Oximeter
    K212555 Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
    K212153 Biobeat Platform, BB-613WP Patch
    K211140 Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2
    K212300 Pulse Oximeter
    K211400 Pulse Oximeter
    K211632 Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
    K210305 Pulse Oximeter
    K211407 Belun Ring BLR-100X
    K212876 Carescape SpO2 - Masimo
    K210032 Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
    K210274 Fingertip Pulse Oximeter
    K201887 VS Newborn Heart Rate Monitor
    K203854 Pulse Oximeter
    K202776 Fingertip pulse oximeter
    K202743 Med-Link Temp-pulse Oximeter
    K201468 Pulse Oximeter
    K202324 Fingertip Pulse Oximeter
    K202173 Pulse Oximeter
    K201384 Pulse Oximeter
    K202851 Spo2 Sensor
    K201294 Pulse Oximeter
    K201770 Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
    K200414 Pulse Oximeter
    K201360 Reusable and Disposable SpO2 Sensors
    K201179 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable
    K200537 Oxxiom
    K192900 H500 Multi-Sensing Oximetry System
    K193350 Leadtek Fingertip Pulse Oximeter
    K191574 OxSAT 100
    K200069 Disposable SpO2 Sensor
    K192608 Disposable SpO2 Sensor
    K192343 Patient Monitor
    K191403 Pulse Oximeter
    K191279 Disposable SpO2 Sensor
    K191088 Checkme O2 Pulse Oximeter
    K191430 Pulse Oximeter
    K191420 Reusable SpO2 Sensor
    K191417 Belun Ring
    K190869 Pulse Oximeter
    K190792 BB-613WP
    K190399 Beddr 200 System
    K191207 Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System
    K183277 SpO2 Sensor
    K181352 Loop System
    K182887 Masimo Rad-67 Pulse CO-Oximeter and Accessories
    K181738 Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
    K183067 Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
    K182822 Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
    K183556 oCare Wrist Pulse Oximeter
    K181956 Masimo MightySat Rx Fingertip Pulse Oximeter
    K180380 vital signs monitor
    K180685 AS-3XX Series Fingertip Pulse Oximeter
    K172792 Handheld Pulse Oximeter, Model SP-20
    K180046 Masimo Rad-97 and Accessories
    K181503 Fingertip Pulse Oximeter
    K181006 BB-613 Watch Oximeter
    K181270 Disposable SpO2 Sensors, Reusable SpO2 Sensors
    K173368 Reusable & Disposable SpO2 Sensors
    K172492 Optical Topography System ETG-4100
    K173123 Pulse Oximeter
    K172616 Pulse Oximeter
    K172981 Reusable SpO2 Sensors, Disposable SpO2 Sensors
    K173045 Oximeter
    K180174 Belun Ring
    K172625 Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
    K172141 Pulse Oximeter
    K171241 Pulse Oximeter
    K172366 Wrist Pulse Oximeter
    K172482 The Nellcor pulse oximetry monitor interface cable
    K170965 Fingertip Pulse Oximeter
    K163135 Finger Pulse Oximeter
    K171423 Nasal Alar SpO2 Sensor
    K163382 Oxitone 1000
    K161938 Fingertip Pulse Oximeter
    K162580 Guardian Angel GA1000 Digital Vital Sign Monitoring System
    K162014 Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
    K153184 Caremed Reusable & Disposable SPO2 Sensors
    K162675 Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter
    K160231 Model X-100C CO-Met™ Oximetry System
    K160940 Masimo Disposable Transflectance Forehead Sensor
    K153021 Fingertip Pulse Oximeter A310
    K160268 Fingertip Pulse Oximeter MD300CG11/MD300CG51
    K161560 Fingertip Pulse Oximeter MD300CN310
    K160582 WiCap
    K152390 Medke Oximetry Finger Sensor
    K152091 Fingertip Pulse Oximeter
    K152089 Wrist Pulse Oximeter
    K160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
    K152563 Pulse Oximeter (MD300M/MD300K2)
    K151024 Finger Type Pulse Oximeter
    K151287 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
    K150314 Masimo MightySat Rx Fingertip Pulse Oximeter
    K151206 Fingertip Pulse Oximeter
    K150093 Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
    K141362 PULSE OXIMETER CMS50EW
    K142687 Pulse Oximeter
    K142865 Nellcor Bedside SpO2 Patient Monitoring System
    K142959 Vyntus Walk
    K143216 Assurance Alar / Nasal SpO2 Sensor
    K141518 Nellcor Bedside Respiratory Patient Monitoring System
    K142888 Fingertip Pulse Oximeter
    K142832 Unimed Disposable and Reusable SPO2 Sensors
    K142209 Pulse oximeter NBM-200
    K141024 EXTERNAL PULSE OXIMETER
    K141105 PULSE OXIMETER
    K141542 NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
    K140582 FINGERTIP PULSE OXIMETER
    K141128 FINGERTIP PULSE OXIMETER
    K132516 OXIPROBE E (OXIPROBE)
    K140682 FINGERTIP PULSE OXIMETER
    K140785 PULSE OXIMETER
    K133064 MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
    K133090 OXICARE FINGERTIP PULSE OXIMETER
    K132402 SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
    K130320 BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
    K124041 NBM-200MP
    K131047 FINGERTIP PULSE OXIMETER
    K130947 FINGERTIP PULSE OXIMETER
    K132696 TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
    K131111 IHEALTH FINGERTIP PULSE OXIMETER
    K131021 PULSE OXIMETER
    K131818 VITAL SIGNS MONITOR
    K123797 NT1D VITAL SIGNS MONITOR
    K123801 FINGER PULSE OXIMETER
    K123871 FINGERTIP PULSE OXIMETER
    K123581 NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
    K120984 MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
    K122996 ASSURANCE ALAR SENSOR MODEL 10078; AB-N ADAPTER CABLE MODEL 10085
    K113727 SHENZHEN MED-LINK PULSE OXIMETER PROBE
    K122046 WRIST PULSE OXIMETER
    K122927 OXICARE FINGERTIP PULSE OXIMETER
    K120502 PC-60NW FINGERTIP OXIMETER
    K121697 FINGERTIP PULSE OXIMETER
    K121806 BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE
    K120657 MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
    K121914 MASIMO SET USPO2 PULSE OXIMETRY CABLE
    K120052 CVINSIGHT
    K121912 E1 EAR SENSORS
    K120773 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM
    K112843 PULSE OXIMETER
    K113865 PULTOL
    K113596 MASIMO SET REUSABLE OXIMETRY SENSORS
    K112804 FINGERTIP PULSE OXIMETER
    K111494 HANDHELD PULSE OXIMETER
    K111403 MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
    K111617 PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
    K110893 VTRUST FINGER TYPE PULSE OXIMETER
    K111621 MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
    K111888 MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
    K112465 VITAL SIGNS MONITOR
    K103802 TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
    K103285 DIXTAL DZ-4100 SERIES PULSE OXIMETER
    K103685 PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
    K103584 ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
    K110028 MASIMO RADICAL Y PULSE CO-OXIMETER
    K103700 ESSENTIAL MRI PATIENT MONITOR
    K102270 ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
    K100225 PULSE OXIMETER MODEL P10
    K101995 CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
    K102835 VITAL SIGNS MONITOR
    K102350 PULSE OXIMETER
    K101012 V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201
    K101577 MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
    K101539 VITAL SIGNS MONITOR MODEL M3B
    K101031 MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
    K101896 MASIMO LNCS/M-LNCS OXIMETRY SENSORS
    K092641 CHARMCARE TABLETOP PULSE OXIMETER
    K100077 NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
    K101871 TRUSIGNAL SPO2 FINGERTIP SENSOR
    K101568 MODEL SB100II FINGER PULSE OXIMETER
    K102442 E.S.O. (ELECTRO SENSOR OXI)
    K101694 HANDHELD PULSE OXIMETER MODEL M800
    K101600 INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
    K100428 MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
    K100403 MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
    K100815 OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316
    K093853 SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
    K100617 MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D
    K100203 HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
    K094046 LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
    K093016 VITAL SIGNS MONITOR
    K091564 NBM-200MP PULSE OXIMETRY DEVICE
    K093881 TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
    K092950 SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
    K100020 DX SERIES FINGER SENSOR
    K093306 SINGLE-PATIENT USE DISPOSABLE SENSOR
    K093757 MD300C1 FINGERTIP PULSE OXIMETER
    K092652 FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
    K092620 MD300C318 FINGERTIP PULSE OXIMETER
    K092727 H100B PULSE OXIMETER
    K092549 OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
    K091241 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
    K092101 REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
    K092838 MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
    K091787 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
    K092678 EVISION DATA MANAGEMENT SOFTWARE
    K091572 DISPOSABLE SPO2 SENSOR M1134A
    K092324 SPIROPRO
    K083448 CABLE, TRANSDUCER, MODEL 2400GN
    K090662 MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
    K090438 REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
    K090599 MD300K1 PULSE OXIMETER
    K091057 MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
    K090165 RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
    K090671 PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
    K083010 SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR
    K083821 VITAL SIGNS MONITOR
    K090360 PHILIPS M3001A MULTI MEASUREMENT SERVER
    K083557 BCI WW1030 PULSE OXIMETER
    K090205 BCI WW1021 PC APPLICATION
    K083351 PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P
    K083787 BCI WW1000 PULSE OXIMETER, MODEL WW1000
    K083705 BCI WW1020 PULSE OXIMETER, MODEL WW1020
    K083466 MD2000A VITAL SIGN MONITOR, MODEL MD2000A
    K082846 APK SPO2 PULSE OXIMETER SENSOR
    K083622 LNCS OXIMETRY SENSORS
    K083892 FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
    K083325 N-600X WITH SPD, OXIMAX N-600X
    K083079 QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
    K082487 M-50 SERIES SPO2 SENSOR
    K082268 CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
    K081033 MIROXI
    K082789 G1B PULSE OXIMETER
    K082546 REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
    K082888 INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
    K082641 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
    K082052 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
    K080348 OXISCAN II DATA MANAGEMENT SYSTEM
    K081572 SMARTSIGNS MINPULSE
    K081800 T12S TELEMETRY TRANSMITTER
    K081712 FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700
    K081659 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
    K081937 PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE
    K081870 MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
    K073249 SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
    K081125 WRIST PULSE OXIMETER MD300W
    K081285 FINGER PULSE OXIMETER, MODEL 9560
    K080255 NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
    K080238 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
    K073454 FINGERTIP PULSE OXIMETER, MODEL CMS-50C
    K071642 MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
    K073036 FORE-SIGHT, MC-2000 SERIES
    K073024 MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
    K072825 FINGERTIP PULSE OXIMETER, MODEL MD300I
    K072581 PM-60 PULSE OXIMETER
    K071610 MEDIAID PULSE OXIMETER M30 AND M34
    K072235 PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
    K072295 CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
    K071672 SENTEC DIGITAL MONITORING SYSTEM
    K070371 FINGERTIP PULSE OXIMETER MD300C
    K071415 DIGITAL PULSE OXIMETER, MODEL 7500FO
    K063641 PC-60, NON-INVASIVEPULSE OXIMETER
    K071285 DIGITAL PULSE OXIMETER, MODEL 7500
    K070732 BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
    K071024 MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
    K062149 SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
    K070408 DURAMAX REUSABLE OXIMETRY SENSOR
    K062724 ACCUPULSE PULSE OXIMETER
    K063752 LIFESENSE, MODEL LS1-9R
    K070193 ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
    K063783 PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
    K061896 MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N
    K061706 CADWELL EASYNET OXIMETER MODULE
    K061931 SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101
    K063434 TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
    K063140 RAINBOW ADHESIVE CO-OXIMETRY SENSORS
    K053420 TENACORE SP02 SENSORS
    K062605 PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
    K062455 PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
    K062338 TELEVISIT
    K062268 MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
    K052544 PULSE OXIMETER ADAPTER CABLES
    K061442 PULSE OXIMETER, MODEL PM-50
    K060576 NELLCOR OXIMAX N-600X PULSE OXIMETER
    K061204 MASIMO SET RADICAL 7 PULSE CO-OXIMETER
    K060675 ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
    K061329 INFINITY MASIMO SET SP02 POD
    K060616 NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100
    K060143 LNCS AND SPO2.COM SENSORS
    K060524 DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
    K053381 WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
    K061191 FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
    K061112 CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
    K053419 KONICA MINOLTA PULSOX-300, 300I
    K060065 CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
    K060843 MODIFICATION TO HEALTH BUDDY APPLIANCE
    K052693 PM-50 PULSE OXIMETER
    K053477 MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
    K053130 ONYX II FINGER PULSE OXIMETER, MODEL 9550
    K051271 OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
    K052619 THE FINGER GUARD
    K052669 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
    K051257 ADULT CEREBRAL OXIMETER, MODEL 2040
    K053269 MASIMO SET RAD-8 PULSE OXIMETER
    K051736 FOX PULSE OXIMETER
    K052377 PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
    K052829 WRISTOX MODEL 3100 PULSE OXIMETER
    K052186 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
    K052755 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
    K051352 OXIMAX NPB-40 HANDHELD PULSE OXIMETER
    K051439 LNOP BLUE OXIMETRY SENSOR
    K051212 MODIFICATION TO LNCS OXIMETRY SENSORS
    K050018 TESLAOXYSAT, MODEL EFOXYSATE
    K050844 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL
    K050056 MODEL 2500A PALMSAT PULSE OXIMETER
    K051107 ONYX II FINGER PULSE OXIMETER, MODEL 9550
    K050252 AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS
    K043463 ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS
    K050068 LNOPV AD-L AND PD-L OXIMETRY SENSORS
    K042536 MASIMO SET RAD 57 PULSE CO-OXIMETER
    K043359 4100 PATIENT OXIMETER MODULE
    K043162 PMP4 OXY PRO
    K042705 DISPOSABLE NON-ADHESIVE SPO2 SENSORS
    K042704 REUSABLE FINGER CLIP SPO2 SENSORS
    K042306 PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
    K042501 ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
    K042346 LNCS OXIMETRY SENSORS
    K041964 MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
    K041522 FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS
    K040178 PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
    K041647 FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
    K040380 DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
    K032831 PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200
    K032971 TIDAL WAVE SP MODEL 710/715 AND 715
    K032949 SPOT CHECK PULSE OXIMETER,512/513
    K041815 LNCS OXIMETRY SENSORS
    K041644 FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
    K041674 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT
    K041204 NC SP02 ADAPTER CABLE
    K041156 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
    K040589 MODIFICATION TO AVANT 9600 PULSE OXIMETER
    K040581 MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
    K032755 MODEL 509M PULSE OXIMETER, MODEL 509M
    K033307 NVISION DATA MANAGEMENT SOFTWARE
    K040259 MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
    K033998 MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
    K033876 DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422
    K040214 MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K032979 PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T
    K033296 MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
    K032551 MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
    K033715 PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
    K033349 AC-1 SP02 ADAPTOR CABLE, MODEL AC-1
    K033298 SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS
    K032537 DRAEGER MICRO2+ AND MASIMO MINISAT
    K031515 SPIROPRO SPO2
    K032947 NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210
    K030668 MODEL 3100 WRISTOX PULSE OXIMETER
    K031465 MODEL 2100 PULSE OXIMETER
    K030629 DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER
    K031740 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES
    K031742 BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
    K030973 PICOSAT II SPO2 PULSE OXIMETRY MODULE
    K023044 MODEL 9600, AVANT PULSE OXIMETER
    K030640 SIEMENS MICRO2+ WITH VAI SOFTWARE
    K030930 OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
    K030952 DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
    K031330 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K024300 MICROCAP PLUS/NPB-75
    K024235 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER
    K012706 IM2001 PULSE OXIMETER
    K021469 MINOLTA PULSOX-2
    K011518 VITALSAT SERIES
    K014218 OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'
    K021955 TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
    K022084 ATLAS MONITOR, MODELS 200,210,220
    K022819 NELLCOR N-200 PULSE OXIMETER, MODEL N-200
    K022163 WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
    K022677 MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE
    K022766 SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
    K022193 DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N
    K022168 ENVOY
    K012770 INFINITY MICRO2+
    K021778 PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
    K021959 DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100
    K021089 OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR
    K020739 BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR
    K021246 SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3
    K021090 OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
    K020350 BCI 3180 PULSE OXIMETER
    K014025 HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER
    K020479 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
    K012989 DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
    K012891 OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
    K013862 BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
    K011974 SENSAID
    K020075 MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
    K014294 MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
    K013319 NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
    K013171 3420 DIGIT PULSE OXIMETER, MODEL 3420
    K013273 FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
    K013792 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K012626 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR
    K011365 VITALSAT PULSE OXIMETER, MODEL IC32000
    K012992 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES
    K012533 MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
    K011320 ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
    K010413 MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI
    K011851 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K011670 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE
    K011156 BCI 3403 SLEEP SCREENING PULSE OXIMETER
    K010966 MEDLEY SP02 MODULE, MODEL 8220
    K002848 SPO2 WRAP SENSOR
    K010451 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
    K002036 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
    K003542 PREAMP CABLE, MODEL B400-1011PA
    K000814 FINGER PULSE METER
    K010463 DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
    K010419 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K004044 HOMMED SENTRY III PATIENT MONITOR SYSTEM
    K001708 PROFOX SOFTWARE, MODEL 920M-41
    K002787 MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120
    K003244 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K003167 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K002957 SOLAR SPO2 MODULE WITH MASIMO SET
    K002690 MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500
    K002939 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER
    K002751 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K001842 ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
    K002682 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K002477 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
    K001995 SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
    K002574 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
    K984570 MINOLTA PULSOX-3/MINOLTA PULSOX-3I
    K002223 EPIC SPO2 FINGER SENSOR, MODEL E412-20
    K001930 MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
    K001770 BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
    K001688 DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
    K000831 STAT-SHELL DISPOSABLE SP02 SENSOR
    K001308 MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
    K001085 MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
    K994372 MODEL 120
    K000126 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
    K000794 MODIFICATION TO MARSPO2, MODEL 2001
    K993512 DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
    K992215 MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED
    K993979 MARSPO2, MODEL 2001
    K992455 NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
    K992211 SPO2 WRAP SENSOR
    K992092 STAT-SHELL DISPOSABLE SPO2 SENSOR
    K981655 SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
    K993637 N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
    K993555 MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
    K992340 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE
    K992238 MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)
    K991823 N-395 PULSE OXIMETER, MODEL N-395
    K991819 MAGNATEK 30
    K991410 3402 HANDHELD PULSE OXIMETER
    K990966 MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS
    K991661 SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
    K990082 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
    K982728 NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
    K983684 DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
    K982776 9303 NEONATAL/ADULT VITAL SIGNS MONITOR
    K982255 MODEL 2000 PULSE OXIMETER
    K973970 SPO2 FINGER PROBES
    K982907 MAGNATEK 40
    K982405 MTEK-1000
    K982331 KELLER PULSE OXIMETER, MODEL 850+
    K981939 AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
    K980879 OSCILLOMATE NIBP / SP02 EMS MONITOR
    K974292 NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
    K970098 E100 SERIES SPO2 SENSORS
    K980299 APEX OXIMETER
    K980714 BCI 3401 HANDHELD PULSE OXIMETER
    K973991 METRON QA-510 SPO2 ANALYZER
    K973887 MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES
    K973147 NPB-295 PULSE OXIMETER
    K972829 CRICKET 2000 RECORDING PULSE OXIMETER
    K972837 NPB-290 PULSE OXIMETER (NPB-290)
    K972786 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366
    K971628 SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
    K971273 INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
    K972468 NPB-195 PULSE OXIMETER
    K970061 ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
    K973222 SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
    K970769 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
    K971946 NPB-190 PULSE OXIMETER (NPB-190)
    K971828 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
    K971827 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
    K965172 OXIMETER PRE-AMP CABLE
    K964821 COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
    K970763 MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
    K971235 ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
    K964978 VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
    K970368 SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
    K964055 FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)
    K945290 8500A PULSE OXIMETER
    K962603 MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
    K963707 NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
    K952315 SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
    K963496 OXI TEMP
    K962127 OHMEDA 3800 PULSE OXIMETER
    K954168 E100A PULSE OXIMETER FINGER SENSOR/PROBE
    K962156 3304 PULSE OXIMETER
    K961450 SCORE SOFTWARE
    K960614 SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
    K960058 OXITEMP, 3301T SA
    K954267 BURDICK 200 PULSE OXIMETER
    K960251 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR
    K940933 9267 SPO2 ATHENA MODULE
    K953817 ARISTO MEDICAL MODEL 2101 PATIENT MONITOR
    K953126 OXILINK (SMALL, MEDIUM, LARGE)
    K952327 SMARTSAT PULSE OXIMETRY ANALYZER
    K952316 NELLCOR SYMPHONY N-3000 PULSE OXIMETER
    K952222 NELLCOR N-20PA PORTABLE PULSE OXIMETER
    K945754 NEWOX2
    K942347 NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000
    K943842 PULSE OXIMETER MODEL 305
    K946185 3301T OXITEMP
    K942842 HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE
    K945464 FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE
    K942248 MINIATURIZED FINGER CLIP PULSE OXIMETER
    K943817 MARQUETTE ADULT/NEONATAL WRAP SENSOR
    K943456 AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
    K943404 3301 PULSE OXIMETER
    K941351 BURDICK PRO2 OXIMETER
    K944608 HP M1722A/B AND M1723A/B CODEMASTER
    K931304 OHMEDA HAND HELD OXIMETER
    K933519 INDEX SPO2 SIMULATOR
    K933755 SENSOR SHIELD, MODIFICATION
    K932203 VITALMAX 530
    K935510 VX4 RECORDING PULSE OXIMETER
    K941289 PULSE OXIMETER
    K920083 BIOCHEM MODEL 3302 NEWOX2 OXIMETER
    K921454 FUKUDA DENSHI MODEL HG-301
    K934091 OXISAT
    K940463 NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS
    K924626 NOVAMETRIX MODEL 510
    K924752 FREEDOM OXIMETER/EEG DIGITAL INTERFACE
    K920966 SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)
    K915699 NELLCOR PORTABLE PULSE OXIMETER MODEL N-20
    K924285 MODEL 3500 MR-COMPATIBLE PULSE OXIMETER
    K924282 MODEL 320 MR-COMPATIBLE PULSE OXIMETER
    K920066 PALCO LABS MODEL 340 PULSE OXIMETER
    K923418 9293/1 INTERFACE MODULE
    K925542 OXYSHUTTLE II ,MODIFICATION
    K923343 HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
    K920082 BIOCHEM MODEL 3301 NEWOX1 OXIMETER
    K910811 SENSOR SHIELD
    K922075 AVOXIMETER
    K921519 OXICOM-2100
    K923682 MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
    K920379 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
    K914538 UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER
    K915773 P-300 CAPNOGRAPH AND PULSE OXIMETER
    K910077 CRIT-SCAN
    K914620 HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION
    K913790 SENSORMEDICS OXYSHUTTLE II(TM)
    K912880 VITALMAX 510/520
    K913695 NELLCOR(R) N-180 PULSE OXIMETER
    K913516 MODEL 520A NOVAMETRIX PULSE OXIMETER
    K911761 SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
    K913489 SIEMENS MICRO2 PULSE OXIMETER
    K913332 CIBA CORNING MODEL 270 CO-OXIMETER
    K911207 OXICOMPLUS
    K910001 MODEL 8604-FO PULSE OXIMETER
    K911191 PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR
    K911124 503 PULSE OXIMETER
    K905310 MINIOX V PULSE OXIMETER
    K905140 SATLITE PLUS PULSE OXIMETER
    K910770 504US PULSE OXIMETER
    K910629 AP-860PA NIBP MODULE
    K910521 SYSTEM 7300 PULSE OXIMETER
    K904988 PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
    K904088 ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC
    K904039 REFLECTANCE SENSOR (RS-10)
    K900001 COROMETRICS MODEL 556 NEONATAL MONITOR
    K903523 HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
    K902730 SPO2 OPTION
    K903702 MODEL 90421 FLEXPORT INTERFACE
    K902779 MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
    K901066 VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.
    K902758 COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
    K902192 MODEL MSC SA02-5000 PULSE OXIMETER
    K901504 MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.
    K900757 ITC ANGIOGRAPHIC CATHETER
    K896738 TYPE 9293 INTERFACE PULSEOX
    K901819 MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
    K901071 PULSE OXIMETRY MODULE
    K901399 POWERBASE II (PB2)
    K902060 ESCORT MODEL 300
    K901774 HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
    K892217 CAV SAT OXIMETER MODEL 100
    K901060 EDENTEC MODEL 2000W SYSTEM 700 MONITOR
    K894100 OXYTRAK(TM) PULSE OXIMETER
    K901612 VITALMAX 2000 ECG MONITOR W/NON-INVASIVE BLOOD-PRE
    K901209 MODEL 90489 PULSE OXIMETER MODULE
    K900866 OXIMAX 700
    K900843 OXIMAX 100
    K893221 MODEL 8500 HAND HELD PULSE OXIMETER
    K895987 KELLER PULSE OXIMETER - KMS 850
    K893643 NOVAMETRIX MDLS 500A, 505A, 515A, & 7000A OXIMETER
    K895425 MINIMON 7137B PATIENT MONITOR
    K892120 ESCORT PULSE OXIMETRY OPTION
    K893867 CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
    K893587 OXIMETER
    K893470 SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE
    K884121 TYPE 9266 SAO2 SYSTEM ATHENA
    K890753 SATLITE TRANS PORTABLE PULSE OXIMETER
    K890299 KONTRON PULSE OXIMETER 7840
    K884822 MODEL OX-1 OXYGEN SATURATION MODULE
    K884050 CNS-8200A CENTRAL NURSES STATION
    K890033 MODEL 8700 PULSE OXIMETER
    K884536 AL-800PA PULSE OXIMETER MODULE
    K884614 EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.
    K884891 OC-100 OXIMETER INTERFACE CALIBRATOR
    K884329 SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
    K881307 OLV 1100; OLV 1200 PULSE OXIMETERS
    K883877 BM-103 BATTERY MODULE
    K873624 KONTRON PULSE OXIMETER 7840
    K883297 HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
    K880756 MODEL PM-20A PHYSIOLOGICAL MONITOR
    K882664 MRL OXIMETER
    K882273 HORIZON 2000 PULSE OXIMETRY AND MODULE
    K881883 SATLITE+/PB251+ PULSE OXIMETER
    K881820 EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
    K881136 HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
    K880672 SENTINEL PULSE OXIMETER
    K872520 SS-1000 POLYGRAPH
    K874492 LAWRENCE L4000 REFLECTANCE PULSE OXIMETER
    K874198 VITALOG HMS-3000
    K875298 502-US PULSE OXIMETER
    K873896 SIMED S-100 PULSE OXIMETER
    K874442 DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
    K875031 OXYGEN/PULSE MONITOR
    K874947 MODEL 8800 CARDIORESPIRATORY OXIMETER
    K874692 PULSEMATE BX-5
    K873199 OHMEDA 4700 OXICAP MONITOR
    K874132 MINIOX IV PORTABLE PULSE OXIMETER
    K873859 CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104
    K874104 OHMEDA BIOX 3760 PULSE OXIMETER
    K873081 EDENTEC MULTI-CHANNEL RECORDER
    K873065 MODEL 7200A WITH PULSE OXIMETRY
    K872772 OHMEDA BIOX 3740 PULSE OXIMETER
    K863857 PULSE-OX
    K873078 NOVAMETRIX MODEL 505 PULSE OXIMETER
    K872626 OXIMETRY MODULE
    K871826 PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE
    K871864 PB240 PATIENT MONITOR/PULSE OXIMETER
    K871353 OXIMETER
    K864730 INVIVO PULSE OXIMETER, MODEL 4500
    K870621 SATLITE/PB251 PULSE OXIMETER
    K864279 SPACELABS MODEL 90419 PULSE OXIMETER MODULE
    K864613 502 OXYGEN SATURATION MONITOR
    K870163 BIOCHEM MICROSPAN 1040 OXIMETER
    K863918 MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
    K863855 ACCUSAT
    K862812 NELLCOR MVP, MODEL N-1000
    K863784 NELLCOR N-200 (PULSE OXIMETER)
    K863186 BIOCHEM CO/OX 1000
    K862617 SENSORMEDICS OXYSHUTTLE(TM)
    K862798 MINIOX 100 PULSE OXIMETER
    K862161 OSC-80 OXIMETER
    K860051 MODEL 8604 OXYGEN/PULSE MONITOR
    K855027 PULSE OXIMETER
    K844256 NELLCOR PULSE OXIMETER N-10
    K833973 MINOLTA SM-32 OXYGEN SATURATION MONIT
    K833826 BTI BIOX III OXIMETER CRITICAL CAREUNI
    K822909 PULSE OXIMETER MODEL 100
    K820110 BIOX III
    K781879 HEATER, OXIMETER SYSTEM
    K780625 UNISTAT OXIMETER

    FEI Numbers

    This FDA classification entry is associated with 403 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 403 registration numbers. Click on an entry to view related FDA registrations.