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

    AIRLIFE ELECTRONIC INCENTIVE SPIROMETER

    K Number: K851334 · Decision Aug 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    64
    Review Days
    127

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    Basic Information

    Device Name
    AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
    K Number
    K851334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    April 1, 1985
    Decision Date
    August 6, 1985
    Product Code
    BWF
    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
    BWF Spirometer, Therapeutic (Incentive)

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    Other Clearances by American Pharmaseal Div. Ahsc

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    K871429 ANTIMICROBIAL FOLEY CATHETER
    K871770 AMERICAN PHARMASEAL WOUND DRESSING
    K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
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