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

    MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)

    K Number: K953434 · Decision May 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    26
    Applicant Total
    12
    Review Days
    300

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    Basic Information

    Device Name
    MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
    K Number
    K953434
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4370
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Midas Rex Pneumatic Tools, Inc.
    Date Received
    July 21, 1995
    Decision Date
    May 16, 1996
    Product Code
    HBB
    Advisory Committee
    Neurology
    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
    HBB Motor, Drill, Pneumatic

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    Other Clearances by Midas Rex Pneumatic Tools, Inc.

    K Number Device Name
    K972289 MIDAS REX MOTOR
    K970965 MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
    K962483 MIDAS REX III MOTOR
    K954076 MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS
    K953433 MIDAS REX TELESCOPING SYSTEM
    K953432 ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS
    K952463 GS & GS20 SURGICAL TOOL SYSTEM
    K952300 MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS)
    K900388 MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
    K854462 MIDAS REX SURGICAL RUBBER DAM
    Search all 12 clearances from Midas Rex Pneumatic Tools, Inc. →