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

    AUTOWAND(TM) 7XXX SERIES, MODIFICATION

    K Number: K904888 · Decision Jan 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    38
    Review Days
    82

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    Basic Information

    Device Name
    AUTOWAND(TM) 7XXX SERIES, MODIFICATION
    K Number
    K904888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Laboratories
    Date Received
    October 26, 1990
    Decision Date
    January 16, 1991
    Product Code
    CAC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAC Apparatus, Autotransfusion

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