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

    BIO-INDUSTRY STIM POCHE(R)

    K Number: K894786 · Decision Sep 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    BIO-INDUSTRY STIM POCHE(R)
    K Number
    K894786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    The Hader Corp.
    Date Received
    August 1, 1989
    Decision Date
    September 29, 1989
    Product Code
    BXN
    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
    BXN Stimulator, Nerve, Battery-Powered

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