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

    AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE

    K Number: K992719 · Decision Jan 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    9
    Review Days
    153

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    Basic Information

    Device Name
    AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
    K Number
    K992719
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amsino Intl., Inc.
    Date Received
    August 12, 1999
    Decision Date
    January 12, 2000
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Amsino Intl., Inc.

    K Number Device Name
    K070873 AMSURE BLADDER IRRIGATION SET
    K974042 AMSURE CLEANSING ENEMA SET
    K973107 AMSINO I.V. ADMINISTRATION SET
    K973199 AMSINO SUCTION CATHETER
    K971929 AMSINO URINARY LEG BAG
    K964745 AMSINO URINARY DRAINAGE BAG
    K950780 AMSINO CERVICAL SCRAPER
    K951528 AMSINO DISPOSABLE VIGINAL SPECULUM