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

    PORTABLE OPERAT. RM. MONITORS HS30/40

    K Number: K832356 · Decision Oct 28, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    102

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    Basic Information

    Device Name
    PORTABLE OPERAT. RM. MONITORS HS30/40
    K Number
    K832356
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6175
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medtel Pty. , Ltd.
    Date Received
    July 18, 1983
    Decision Date
    October 28, 1983
    Product Code
    BZN
    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
    BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)

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