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

    ADR ULTRASOUND MODELS 4000S & 4000S/L

    K Number: K813543 · Decision Feb 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    10
    Review Days
    65

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    Basic Information

    Device Name
    ADR ULTRASOUND MODELS 4000S & 4000S/L
    K Number
    K813543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Adr Ultrasound
    Date Received
    December 21, 1981
    Decision Date
    February 24, 1982
    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 Adr Ultrasound

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    K828049 ADR ULTRASOUND MC2 LARGE CART
    K828051 ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC
    K828053 ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER
    K828050 ADR ULTRASOUND MODEL 4000 L
    K812301 VARIABLE FOCUS 3.5 MHZ TRANSDUCER
    K792446 ADR REAL-TIME SECTOR SCANNER