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

    ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE

    K Number: K912563 · Decision Oct 2, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    113

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    Basic Information

    Device Name
    ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE
    K Number
    K912563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mbo Laboratories, Inc.
    Date Received
    June 11, 1991
    Decision Date
    October 2, 1991
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Mbo Laboratories, Inc.

    K Number Device Name
    K922468 ANGEL WING SETS -- MODIFIED
    K920184 ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.