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

    IMEX DOP-TONE II

    K Number: K901593 · Decision Jul 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    19
    Review Days
    88

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    Basic Information

    Device Name
    IMEX DOP-TONE II
    K Number
    K901593
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Imex Medical Systems, Inc.
    Date Received
    April 5, 1990
    Decision Date
    July 2, 1990
    Product Code
    KNG
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNG Monitor, Ultrasonic, Fetal

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    Other Clearances by Imex Medical Systems, Inc.

    K Number Device Name
    K973556 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000
    K973562 IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100
    K973336 IMEX STETHODOP
    K970156 IMEX FUTURALDOP PRO
    K942243 IMEX 8000 PERSONAL CASCULAR LAB
    K944196 IMWXDOP IR
    K942441 IMEXDOP CT+
    K910462 POCKET DOP 3
    K896613 FLAT VASCULAR PROBE
    K882138 IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER
    Search all 19 clearances from Imex Medical Systems, Inc. →