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

    HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)

    K Number: K994373 · Decision Mar 24, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4)
    K Number
    K994373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atl Ultrasound, Inc.
    Date Received
    December 27, 1999
    Decision Date
    March 24, 2000
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

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