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

    OMNISTICK

    K Number: K830310 · Decision May 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    57
    Applicant Total
    32
    Review Days
    119

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    Basic Information

    Device Name
    OMNISTICK
    K Number
    K830310
    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
    January 26, 1983
    Decision Date
    May 25, 1983
    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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