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

    TRAUMA CARE EVALUATION

    K Number: K843905 · Decision Sep 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    358

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    Basic Information

    Device Name
    TRAUMA CARE EVALUATION
    K Number
    K843905
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Quantitative
    Date Received
    October 3, 1984
    Decision Date
    September 26, 1985
    Product Code
    PLB
    Advisory Committee
    Cardiovascular
    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
    PLB Multivariate Vital Signs Index

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