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

    PHYSIOTECH 4000 OR NORODYN 8000

    K Number: K922270 · Decision Sep 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    171
    Applicant Total
    6
    Review Days
    841

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    Basic Information

    Device Name
    PHYSIOTECH 4000 OR NORODYN 8000
    K Number
    K922270
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5050
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myo-Tronics, Inc.
    Date Received
    May 14, 1992
    Decision Date
    September 2, 1994
    Product Code
    HCC
    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
    HCC Device, Biofeedback

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