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

    SOMATOSENSORY STIMULUS SYSTEM

    K Number: K913604 · Decision Dec 9, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    117

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    Basic Information

    Device Name
    SOMATOSENSORY STIMULUS SYSTEM
    K Number
    K913604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1880
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biomagnetic Technologies, Inc.
    Date Received
    August 14, 1991
    Decision Date
    December 9, 1991
    Product Code
    GZP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZP Stimulator, Mechanical, Evoked Response

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