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

    MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS

    K Number: K884165 · Decision Oct 26, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    MUSCLE EXAMINATION & EXERCISE DOSIMETER (MEED) SYS
    K Number
    K884165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1240
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Spark Instruments & Academics, Inc.
    Date Received
    October 4, 1988
    Decision Date
    October 26, 1988
    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 Spark Instruments & Academics, Inc.

    K Number Device Name
    K861396 HANDHELD DYNAMOMETER, MODEL #160 AND #111