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

    RhythmView Workstation

    K Number: K142901 · Decision Dec 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    7
    Review Days
    66

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    Basic Information

    Device Name
    RhythmView Workstation
    K Number
    K142901
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topera, Inc.
    Date Received
    October 14, 2014
    Decision Date
    December 19, 2014
    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 Topera, Inc.

    K Number Device Name
    K151245 Rhythm View Workstation (non-streaming, steaming option)
    K142182 FRIMAP ADAPTER CONNECTOR (MAC)
    K133305 RHYTHM VIEW WORKSTATION
    K130827 FIRMAP CATHETER
    K123295 RHYTHM VIEW
    K110878 RHYTHMVIEW (TM)