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

    RESPIRATION/APNEA AMPLIFIER MODEL 3105

    K Number: K792528 · Decision Feb 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    9
    Review Days
    76

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    Basic Information

    Device Name
    RESPIRATION/APNEA AMPLIFIER MODEL 3105
    K Number
    K792528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Electronics For Medicine, Inc.
    Date Received
    December 7, 1979
    Decision Date
    February 21, 1980
    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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