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

    SONOQUICK ULTRASOUND GEL

    K Number: K931908 · Decision Sep 29, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    5
    Review Days
    531

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    Basic Information

    Device Name
    SONOQUICK ULTRASOUND GEL
    K Number
    K931908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonomed Technology, Inc.
    Date Received
    April 16, 1993
    Decision Date
    September 29, 1994
    Product Code
    IYO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Sonomed Technology, Inc.

    K Number Device Name
    K931909 CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL
    K883917 NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT
    K844031 SONOMED TECH OPHTHALMIC B-SCAN B-3000
    K843696 OPHTHALMIC A-SCAN A-2000 SONOME