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

    MEDIFLEX TRANSDUCER PROTECTOR

    K Number: K863496 · Decision Sep 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    MEDIFLEX TRANSDUCER PROTECTOR
    K Number
    K863496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mediflex Intl.
    Date Received
    September 9, 1986
    Decision Date
    September 23, 1986
    Product Code
    FIB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIB Protector, Transducer, Dialysis

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    Other Clearances by Mediflex Intl.

    K Number Device Name
    K915140 PRIMARY DRESSING TRAY
    K900841 HEMODIALYSIS TRANSDUCER PROTECTOR
    K891077 MEDIVERSE PARENTERAL NUTRITION BAG
    K884243 BLOOD TUBING SET
    K855039 MEDIFLEX INJECTION CAP
    K854346 MEDIFLEX DISPOSABLE TUBING CLAMP
    K852106 I.V. ADMINISTRATION SET
    K843126 MEDIFLEX DRAINAGE BAG