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

    TUBE HOLDING DEVICE

    K Number: K770108 · Decision Mar 10, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    63
    Applicant Total
    24
    Review Days
    52

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    Basic Information

    Device Name
    TUBE HOLDING DEVICE
    K Number
    K770108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    January 17, 1977
    Decision Date
    March 10, 1977
    Product Code
    FPK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPK Tubing, Fluid Delivery

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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
    K781680 MONITORING, PRESSURE KIT
    Search all 24 clearances from Pharmaseal Div., Baxter Healthcare Corp. →