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

    Merge Hemo

    K Number: K152864 · Decision Apr 7, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    8
    Review Days
    190

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    Basic Information

    Device Name
    Merge Hemo
    K Number
    K152864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merge Healthcare Incorporated
    Date Received
    September 30, 2015
    Decision Date
    April 7, 2016
    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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    Other Clearances by Merge Healthcare Incorporated

    K Number Device Name
    K250301 Merge Universal Viewer (MUV)
    K233326 Merge Hemo, Model RCSV2
    K203104 IBM iConnect Access
    K192455 Merge PACS
    K192276 Merge Cardio
    K182290 IBM iConnect Access
    K173475 Merge PACS