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

    Burn Resuscitation Decision Support System - Clinical (BRDSS-C)

    K Number: K140387 · Decision Dec 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    312

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
    K Number
    K140387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Surgeon General, Department of the Army
    Date Received
    February 14, 2014
    Decision Date
    December 23, 2014
    Product Code
    PDT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PDT Burn Resuscitation Decision Support Software

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PDT), ordered by most recent decision date.

    BURN RESUSCITATION DECISION SUPPORT SYSTEM (BRDSS)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by The Surgeon General, Department of the Army

    K Number Device Name
    K143592 GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC