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

    DAYPAK SYS VII CATHETER CARE KIT

    K Number: K840919 · Decision Apr 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    47

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    Basic Information

    Device Name
    DAYPAK SYS VII CATHETER CARE KIT
    K Number
    K840919
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2500
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Creative Care Systems, Inc.
    Date Received
    March 1, 1984
    Decision Date
    April 17, 1984
    Product Code
    KLK
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

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    Other Clearances by Creative Care Systems, Inc.

    K Number Device Name
    K861406 NON-KOR WINGED INFUSION SETS
    K852831 NON-KOR ACCESS KITS
    K850888 PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV
    K850887 DRESSING CHANGE KIT
    K841742 NON-CORING NEEDLE
    K840681 DAYPAK SYSTEM III CATHETER CARE KIT