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

    THE ORTHORANGER II ELECTRONIC GONIOMETER

    K Number: K884611 · Decision Jan 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    32
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    THE ORTHORANGER II ELECTRONIC GONIOMETER
    K Number
    K884611
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1500
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    Medical Instruments Technology, Inc.
    Date Received
    November 4, 1988
    Decision Date
    January 31, 1989
    Product Code
    KQX
    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
    KQX Goniometer, Ac-Powered

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    Other Clearances by Medical Instruments Technology, Inc.

    K Number Device Name
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    K012640 ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
    K012624 REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS
    K012632 TOURNIQUET CUFF; PNEUMATIC TOURNIQUET