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

    IREX CARDIOPLAN

    K Number: K792525 · Decision Dec 27, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    10
    Review Days
    21

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    Basic Information

    Device Name
    IREX CARDIOPLAN
    K Number
    K792525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Irex Corp.
    Date Received
    December 6, 1979
    Decision Date
    December 27, 1979
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Irex Corp.

    K Number Device Name
    K844404 IREX PS, PORTABLE SCANNER AND 118
    K843643 COLOR DOPPLER 880
    K842408 IREX 730 MECHANICAL SECTOR SCANNER
    K840139 IREX 720 SECTOR SCANNER
    K827370 IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM
    K813544 IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.
    K811246 DOPPLER ULTRASOUND BLOOD FLOWMETER
    K791317 IREX REAL TIME PHASED ARRAY SYSTEM
    K771372 SYSTEM II