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

    BLOOD WARMER (CODE 4R4305)

    K Number: K760012 · Decision Jul 16, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    13
    Applicant Total
    206
    Review Days
    36

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    Basic Information

    Device Name
    BLOOD WARMER (CODE 4R4305)
    K Number
    K760012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9205
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    June 10, 1976
    Decision Date
    July 16, 1976
    Product Code
    BSB
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSB Warmer, Blood, Non-Electromagnetic Radiation

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