BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇿 New Zealand

    PERIPHERAL NERVE STIMULATOR MODEL A400

    K Number: K852962 · Decision Dec 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    62
    Applicant Total
    12
    Review Days
    150

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    Basic Information

    Device Name
    PERIPHERAL NERVE STIMULATOR MODEL A400
    K Number
    K852962
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2775
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fisher & Paykel Allied Products , Ltd.
    Date Received
    July 12, 1985
    Decision Date
    December 9, 1985
    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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