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

    KOKO PEAK KP; KOKO PEAK KP+

    K Number: K010009 · Decision Jun 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    79
    Applicant Total
    2
    Review Days
    150

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    Basic Information

    Device Name
    KOKO PEAK KP; KOKO PEAK KP+
    K Number
    K010009
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    868.1860
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pds Healthcare Products, Inc.
    Date Received
    January 2, 2001
    Decision Date
    June 1, 2001
    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 Pds Healthcare Products, Inc.

    K Number Device Name
    K013489 KP + LFM