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

    UMBILICAL ARTERY OXYGEN SENSOR

    K Number: K875225 · Decision Mar 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    22
    Applicant Total
    120
    Review Days
    73

    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
    UMBILICAL ARTERY OXYGEN SENSOR
    K Number
    K875225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1200
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Ohmeda Medical
    Date Received
    December 22, 1987
    Decision Date
    March 4, 1988
    Product Code
    CCE
    Advisory Committee
    Anesthesiology
    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
    CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

    Similar 510(k) Clearances

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

    VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOPS NEEDLE TIP PROBE & PVC TIP PROBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OPTEX BLOOD GAS MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TISSUE OXYGEN MONITOR SYSTEM, MODEL II

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

    Other Clearances by Ohmeda Medical

    K Number Device Name
    K123309 GIRAFFE AND PANDA WARMERS
    K101788 GIRAFFE OMNIBED
    K101778 GIRAFFE INCUBATOR
    K090697 MODIFICATION TO: GIRAFFE AND PANDA WARMER
    K072157 MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
    K070377 GIRAFFE AND PANDA WARMER
    K070210 GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
    K070247 GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
    K040068 BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
    K020543 OHMEDA MEDICAL GIRAFFE OMNIBED
    Search all 120 clearances from Ohmeda Medical →