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

    SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS

    K Number: K843821 · Decision Oct 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    10
    Review Days
    368

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    Basic Information

    Device Name
    SOLCO BASLE INTRAOPERATIVE AUTOTTRNSFUS
    K Number
    K843821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Solco Basle, Inc.
    Date Received
    September 28, 1984
    Decision Date
    October 1, 1985
    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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