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

    ISOFLO(TM) HIGH PRESSURE INJECTION LINES

    K Number: K901382 · Decision Jul 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    ISOFLO(TM) HIGH PRESSURE INJECTION LINES
    K Number
    K901382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Healthdyne Cardiovascular, Inc.
    Date Received
    March 22, 1990
    Decision Date
    July 19, 1990
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Healthdyne Cardiovascular, Inc.

    K Number Device Name
    K901643 ISOFLO(TM) AMNIOCENTESIS TRAY
    K901084 ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
    K900665 DRESSING CHANGE KIT
    K895763 ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING