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

    NK GRASP SENSOR, MODEL GA002

    K Number: K923965 · Decision May 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    15
    Review Days
    278

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    Basic Information

    Device Name
    NK GRASP SENSOR, MODEL GA002
    K Number
    K923965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1240
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nk Biotechnical Engineering Co.
    Date Received
    August 7, 1992
    Decision Date
    May 12, 1993
    Product Code
    LBB
    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
    LBB Dynamometer, Ac-Powered

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    Other Clearances by Nk Biotechnical Engineering Co.

    K Number Device Name
    K934368 NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001
    K923964 NK GRASP SENSOR, MODEL GA001
    K923963 NK DIGI-GRIP SENSOR, MODEL DGR001
    K921266 NK MEDICAL MICROMETER, MODEL MC001
    K921268 NK DYNA-GRIP SENSOR, MODEL DG001
    K914057 NK PINCH SENSOR, MODEL PA001
    K914061 NK RANGE OF MOTION SENSOR, MODEL RM002
    K914056 NK PINCH SENSOR, MODEL PF002
    K914062 NK DEXTERITLY BOARD, MODEL BX001
    K914059 NK DEVIATION SENSOR, MODEL DV001
    Search all 15 clearances from Nk Biotechnical Engineering Co. →