BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS

    K Number: K902632 · Decision Sep 4, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    57
    Applicant Total
    32
    Review Days
    82

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    Basic Information

    Device Name
    GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
    K Number
    K902632
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.1100
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Marquest Medical Products, Inc.
    Date Received
    June 14, 1990
    Decision Date
    September 4, 1990
    Product Code
    CBT
    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
    CBT Arterial Blood Sampling Kit

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