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

    LEVEL 1 BLOOD STREAM RECOVERY SYSTEM

    K Number: K942844 · Decision Apr 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    194
    Applicant Total
    5
    Review Days
    680

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    Basic Information

    Device Name
    LEVEL 1 BLOOD STREAM RECOVERY SYSTEM
    K Number
    K942844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5830
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Level 1 Technologies, Inc.
    Date Received
    June 16, 1994
    Decision Date
    April 26, 1996
    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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