BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SIEMENS MICRO2 PULSE OXIMETER

    K Number: K913489 · Decision Oct 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    15
    Review Days
    85

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SIEMENS MICRO2 PULSE OXIMETER
    K Number
    K913489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Electronics
    Date Received
    August 6, 1991
    Decision Date
    October 30, 1991
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DQA Oximeter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.

    Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Pulse Oximeter (SP61)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Siemens Medical Electronics

    K Number Device Name
    K935043 SIEMENS CLINICAL WORK STATION
    K921930 SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFI
    K920445 SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES
    K914765 SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYS
    K912070 SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNIT
    K905775 SIEMENS ETCO2 CARTRIDGE
    K900319 SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM
    K901771 SIEMENS SIRECUST 732, PATIENT MONITOR
    K894460 SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
    K891481 SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
    Search all 15 clearances from Siemens Medical Electronics →