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

    PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE

    K Number: K961077 · Decision Jul 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    107
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
    K Number
    K961077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5690
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthscan Products, Inc.
    Date Received
    March 18, 1996
    Decision Date
    July 15, 1996
    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 Healthscan Products, Inc.

    K Number Device Name
    K962924 PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
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    K933889 PERSONAL BEST LOW RANGE