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

    REPROCESSED MASIMO PULSE OXIMETER SENSORS

    K Number: K081238 · Decision Jul 29, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    26
    Applicant Total
    21
    Review Days
    89

    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
    REPROCESSED MASIMO PULSE OXIMETER SENSORS
    K Number
    K081238
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ascent Healthcare Solutions
    Date Received
    May 1, 2008
    Decision Date
    July 29, 2008
    Product Code
    NLF
    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
    NLF Oximeter, Reprocessed

    Similar 510(k) Clearances

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

    Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE

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

    Other Clearances by Ascent Healthcare Solutions

    K Number Device Name
    K111600 REPROCESSED HAND ACTIVATE SEALER/DIVIDER
    K110189 REPROCESSED ELECTROSURGICAL INSTRUMENT
    K100909 REPROCESSED COMPRESSION SLEEVES
    K100254 REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
    K100537 REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
    K100080 REPROCESSED TROCARS, MODEL B5LT AND CB5LT
    K093702 REPROCESSED ULTRASONIC COAGULATING SHEARS
    K092425 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
    K090323 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    K082023 REPROCESSED ELECTROPHYSIOLOGY CATHETERS
    Search all 21 clearances from Ascent Healthcare Solutions →