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

    AMUKIN-50% FOR CAPD Y-SET

    K Number: K862928 · Decision Mar 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    5
    Review Days
    220

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    Basic Information

    Device Name
    AMUKIN-50% FOR CAPD Y-SET
    K Number
    K862928
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Amuchina Intl., Inc.
    Date Received
    August 1, 1986
    Decision Date
    March 9, 1987
    Product Code
    FKX
    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
    FKX System, Peritoneal, Automatic Delivery

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    Other Clearances by Amuchina Intl., Inc.

    K Number Device Name
    K992016 AMUKIN D
    K952302 AMUCHINA
    K871583 MODIFIED LABELING FOR AMUKIN-50%
    K852359 AMUCHINA/DIALYZER DISINFECTANT