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

    PERSONAL BEST II

    K Number: K962929 · Decision Oct 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    5
    Review Days
    87

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    Basic Information

    Device Name
    PERSONAL BEST II
    K Number
    K962929
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Healthscan Products, Inc.
    Date Received
    July 29, 1996
    Decision Date
    October 24, 1996
    Product Code
    BZH
    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
    BZH Meter, Peak Flow, Spirometry

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    Other Clearances by Healthscan Products, Inc.

    K Number Device Name
    K962924 PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
    K962822 OPTICHAMBER
    K961077 PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
    K933889 PERSONAL BEST LOW RANGE