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

    ECA

    K Number: K811397 · Decision Jul 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    45

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    Basic Information

    Device Name
    ECA
    K Number
    K811397
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6080
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Gillco, Inc.
    Date Received
    May 18, 1981
    Decision Date
    July 2, 1981
    Product Code
    FOA
    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
    FOA Board, Cardiopulmonary

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