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

    JTECH ADJUSTER REFLEX GUN

    K Number: K974376 · Decision Feb 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    JTECH ADJUSTER REFLEX GUN
    K Number
    K974376
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    J-Tech Medical, Inc.
    Date Received
    November 20, 1997
    Decision Date
    February 18, 1998
    Product Code
    LXM
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXM Manipulator, Plunger-Like Joint

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    Other Clearances by J-Tech Medical, Inc.

    K Number Device Name
    K971407 JTECH COMMANDER AND ALGOMETER