BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    QUANTIX/OR DEVICE

    K Number: K030357 · Decision Aug 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    136
    Applicant Total
    3
    Review Days
    198

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    Basic Information

    Device Name
    QUANTIX/OR DEVICE
    K Number
    K030357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiosonix, Ltd.
    Date Received
    February 3, 2003
    Decision Date
    August 20, 2003
    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 Cardiosonix, Ltd.

    K Number Device Name
    K041180 QUANTIX OR VESSEL STABILIZER DEVICE
    K023431 QUANTIX/ND DEVICE