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

    KT-1000 DEVICE

    K Number: K812806 · Decision Nov 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    35

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    Basic Information

    Device Name
    KT-1000 DEVICE
    K Number
    K812806
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1615
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Medmetric Corp.
    Date Received
    October 6, 1981
    Decision Date
    November 10, 1981
    Product Code
    LYH
    Advisory Committee
    Physical Medicine
    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
    LYH Arthrometer

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    Other Clearances by Medmetric Corp.

    K Number Device Name
    K943197 KT1000/S KNEE LIGAMENT ARTHROMETER
    K942059 KT2000 KNEE LIGAMENT ARTHROMETER
    K904823 FLEXERCYCLE
    K904898 TORQUE FRAME QTF1000
    K854254 TENSION-ISOMETER
    K812713 DRAWER TEST
    K801572 SURG-ASSIST