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510(k) K151245

Rhythm View Workstation (non-streaming, steaming option) by Topera, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2015
Date Received
May 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Topera, Inc.

  • K142901 — RhythmView Workstation (December 19, 2014)
  • K142182 — FRIMAP ADAPTER CONNECTOR (MAC) (September 9, 2014)
  • K133305 — RHYTHM VIEW WORKSTATION (December 16, 2013)
  • K130827 — FIRMAP CATHETER (October 31, 2013)
  • K123295 — RHYTHM VIEW (April 24, 2013)
  • K110878 — RHYTHMVIEW (TM) (September 23, 2011)

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