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

    DISPOSABLE INCENTIVE SPIROMETER

    K Number: K781394 · Decision Oct 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    61
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    DISPOSABLE INCENTIVE SPIROMETER
    K Number
    K781394
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5640
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Inhal-O-Tech Medical Plastic
    Date Received
    August 14, 1978
    Decision Date
    October 16, 1978
    Product Code
    CCQ
    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
    CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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