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

    PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM

    K Number: K981834 · Decision Sep 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    126

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    Basic Information

    Device Name
    PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
    K Number
    K981834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perception, Inc.
    Date Received
    May 26, 1998
    Decision Date
    September 29, 1998
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Perception, Inc.

    K Number Device Name
    K974880 PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
    K972192 PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
    K972973 PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM