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

    DUALTHERM(R) CARDIAC OUTPUT COMPUTER

    K Number: K925285 · Decision Jul 21, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    19
    Review Days
    274

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    Basic Information

    Device Name
    DUALTHERM(R) CARDIAC OUTPUT COMPUTER
    K Number
    K925285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. Braun of America, Inc.
    Date Received
    October 20, 1992
    Decision Date
    July 21, 1993
    Product Code
    DQK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQK Computer, Diagnostic, Programmable

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