BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF

    K Number: K893519 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    99

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    Basic Information

    Device Name
    TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
    K Number
    K893519
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2170
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Statlabs, Inc.
    Date Received
    May 8, 1989
    Decision Date
    August 15, 1989
    Product Code
    KZB
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZB Automated Colony Counter