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

    Rhythm View Workstation (non-streaming, steaming option)

    K Number: K151245 · Decision Sep 15, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    7
    Review Days
    127

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    Basic Information

    Device Name
    Rhythm View Workstation (non-streaming, steaming option)
    K Number
    K151245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topera, Inc.
    Date Received
    May 11, 2015
    Decision Date
    September 15, 2015
    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
    K142901 RhythmView Workstation
    K142182 FRIMAP ADAPTER CONNECTOR (MAC)
    K133305 RHYTHM VIEW WORKSTATION
    K130827 FIRMAP CATHETER
    K123295 RHYTHM VIEW
    K110878 RHYTHMVIEW (TM)