BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AP-4000, AIR PULSE SENSORY STIMULATOR

    K Number: K964815 · Decision Sep 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    67
    Review Days
    279

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    Basic Information

    Device Name
    AP-4000, AIR PULSE SENSORY STIMULATOR
    K Number
    K964815
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    November 29, 1996
    Decision Date
    September 4, 1997
    Product Code
    LLN
    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
    LLN Device, Vibration Threshold Measurement

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