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

    INFANT APNEA MONITOR MODEL 100

    K Number: K812045 · Decision Sep 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    171
    Applicant Total
    14
    Review Days
    65

    Basic Information

    Device Name
    INFANT APNEA MONITOR MODEL 100
    K Number
    K812045
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
    Date Received
    July 21, 1981
    Decision Date
    September 24, 1981
    Product Code
    BZQ
    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
    BZQ Monitor, Breathing Frequency

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