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

    BLOOD/FLUID WARMER MODEL DW-1000A

    K Number: K770232 · Decision Feb 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    7

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    Basic Information

    Device Name
    BLOOD/FLUID WARMER MODEL DW-1000A
    K Number
    K770232
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9205
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gorman Rupp Industries
    Date Received
    February 7, 1977
    Decision Date
    February 14, 1977
    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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