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

    ALARM UNIT, BATTERY OPERATED

    K Number: K781158 · Decision Dec 18, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    109
    Registration Numbers
    109
    Same Product Code
    174
    Applicant Total
    6
    Review Days
    166

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    Basic Information

    Device Name
    ALARM UNIT, BATTERY OPERATED
    K Number
    K781158
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2375
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Thompson Respiration Products, Inc.
    Date Received
    July 5, 1978
    Decision Date
    December 18, 1978
    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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    Other Clearances by Thompson Respiration Products, Inc.

    K Number Device Name
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    K781160 VENTILATOR, MINILUNG
    K781159 VENTILATOR, PRESSURE
    K781161 RESPIRATOR, BANTAM MODEL