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

    AMMOCENTESIS TRAY (KIT)

    K Number: K761230 · Decision Dec 17, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    19
    Applicant Total
    24
    Review Days
    7

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    Basic Information

    Device Name
    AMMOCENTESIS TRAY (KIT)
    K Number
    K761230
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    December 10, 1976
    Decision Date
    December 17, 1976
    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)

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    Other Clearances by Pharmaseal Div., Baxter Healthcare Corp.

    K Number Device Name
    K792369 HYPERALIMENTATION DRESSING TRAY
    K792141 CONTINUOUS FLUSH DEVICE
    K792019 PHADECODE XA INHIBITOR ASSAY
    K791773 VENTILATOR TUBE WITH FILTER
    K791156 AMIPAQUE MYELOGRAM TRAY
    K790896 TWO-WAY ANESTHESIA FILTER
    K790409 LOW DEAD SPACE INSULIN SYRINGE
    K782069 TRAY, AUXILLARY BLOCK
    K781797 PREP TRAY, PREOPERATIVE SKIN
    K781680 MONITORING, PRESSURE KIT
    Search all 24 clearances from Pharmaseal Div., Baxter Healthcare Corp. →