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

    MONITORING, PRESSURE KIT

    K Number: K781680 · Decision Oct 6, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    24
    Review Days
    4

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    Basic Information

    Device Name
    MONITORING, PRESSURE KIT
    K Number
    K781680
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    October 2, 1978
    Decision Date
    October 6, 1978
    Product Code
    DRS
    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
    DRS Transducer, Blood-Pressure, Extravascular

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    Other Clearances by Pharmaseal Div., Baxter Healthcare Corp.

    K Number Device Name
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    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
    K780887 IMPROVED DISPOSABLE HYPODERMIC NEEDLE
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