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

    DINAMAP SELECT MULTI-PARAMETER SYSTEM

    K Number: K955113 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    53
    Review Days
    281

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    Basic Information

    Device Name
    DINAMAP SELECT MULTI-PARAMETER SYSTEM
    K Number
    K955113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Medical, Inc.
    Date Received
    November 8, 1995
    Decision Date
    August 15, 1996
    Product Code
    DPS
    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
    DPS Electrocardiograph

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