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

    DOPPLER ULTRASOUND BLOOD FLOWMETER

    K Number: K811246 · Decision Aug 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    10
    Review Days
    99

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    Basic Information

    Device Name
    DOPPLER ULTRASOUND BLOOD FLOWMETER
    K Number
    K811246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Irex Corp.
    Date Received
    May 5, 1981
    Decision Date
    August 12, 1981
    Product Code
    DPW
    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
    DPW Flowmeter, Blood, Cardiovascular

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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.
    K792525 IREX CARDIOPLAN
    K791317 IREX REAL TIME PHASED ARRAY SYSTEM
    K771372 SYSTEM II