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

    HEMODIALYSIS TRANSDUCER PROTECTOR

    K Number: K900841 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    9
    Review Days
    82

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    Basic Information

    Device Name
    HEMODIALYSIS TRANSDUCER PROTECTOR
    K Number
    K900841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Mediflex Intl.
    Date Received
    February 22, 1990
    Decision Date
    May 15, 1990
    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
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    K855039 MEDIFLEX INJECTION CAP
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    K852106 I.V. ADMINISTRATION SET
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