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

    NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001

    K Number: K934368 · Decision Aug 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    15
    Review Days
    338

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    Basic Information

    Device Name
    NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001
    K Number
    K934368
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nk Biotechnical Engineering Co.
    Date Received
    September 7, 1993
    Decision Date
    August 11, 1994
    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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