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

    EDP 1200 SECTOR SCANNER OPTION

    K Number: K801656 · Decision Sep 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    4
    Review Days
    67

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    Basic Information

    Device Name
    EDP 1200 SECTOR SCANNER OPTION
    K Number
    K801656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Unirad Corp.
    Date Received
    July 21, 1980
    Decision Date
    September 26, 1980
    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 Unirad Corp.

    K Number Device Name
    K801655 AUTO SECTOR SCANNER
    K792638 HIGH RESOLUTION IMAGING SYSTEM
    K770644 ULTRASOUND B-SCANNING SYSTEM