Rhythm View Workstation
FDA 510(k) K133305 · Topera, Inc.
510(k) numberK133305
Submission
- Device name
- Rhythm View Workstation
- Applicant
- Topera, Inc.
St.Louis, MO, US - Received
- October 28, 2013
- Decision date
- December 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151245 | Rhythm View Workstation (non-streaming, steaming option)DQK · Traditional | 09/15/2015SE |
| K142901 | RhythmView WorkstationDQK · Special | 12/19/2014SE |
| K142182 | Frimap Adapter Connector (Mac)MTD · Special | 09/09/2014SE |
| K130827 | Firmap CatheterMTD · Traditional | 10/31/2013SE |
| K123295 | Rhythm ViewDQK · Special | 04/24/2013SE |
| K110878 | Rhythmview (TM)DQK · Traditional | 09/23/2011SE |
Questions and answers
When was Rhythm View Workstation cleared by the FDA?
Rhythm View Workstation (K133305) received a 510(k) decision of Substantially Equivalent on December 16, 2013, 49 days after the submission was received.
What is the product code of K133305?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.