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

    NEUROMETER

    K Number: K853608 · Decision Jun 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    288

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    Basic Information

    Device Name
    NEUROMETER
    K Number
    K853608
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Neurotron, Inc.
    Date Received
    August 28, 1985
    Decision Date
    June 12, 1986
    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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    Other Clearances by Neurotron, Inc.

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