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

    JTECH COMMANDER AND ALGOMETER

    K Number: K971407 · Decision Apr 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    369

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    Basic Information

    Device Name
    JTECH COMMANDER AND ALGOMETER
    K Number
    K971407
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1250
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J-Tech Medical, Inc.
    Date Received
    April 16, 1997
    Decision Date
    April 20, 1998
    Product Code
    HRW
    Advisory Committee
    Orthopedic
    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
    HRW Dynamometer, Nonpowered

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