BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ISOFLO(TM) AMNIOCENTESIS TRAY

    K Number: K901643 · Decision Jul 25, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    19
    Applicant Total
    5
    Review Days
    107

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    Basic Information

    Device Name
    ISOFLO(TM) AMNIOCENTESIS TRAY
    K Number
    K901643
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Healthdyne Cardiovascular, Inc.
    Date Received
    April 9, 1990
    Decision Date
    July 25, 1990
    Product Code
    HIO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

    Similar 510(k) Clearances

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    RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY

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    AMNIOTEST(TM)

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    MEGA AMNIOCENTESIS KIT

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    Other Clearances by Healthdyne Cardiovascular, Inc.

    K Number Device Name
    K901382 ISOFLO(TM) HIGH PRESSURE INJECTION LINES
    K901084 ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO.
    K900665 DRESSING CHANGE KIT
    K895763 ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING