FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHYTHM VIEW
K Number: K123295
·
Decision Apr 24, 2013
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
7
Review Days
184
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Basic Information
- Device Name
- RHYTHM VIEW
- K Number
- K123295
- 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 22, 2012
- Decision Date
- April 24, 2013
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
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Other Clearances by Topera, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151245 | Rhythm View Workstation (non-streaming, steaming option) | Sep 15, 2015 | Substantially Equivalent |
| K142901 | RhythmView Workstation | Dec 19, 2014 | Substantially Equivalent |
| K142182 | FRIMAP ADAPTER CONNECTOR (MAC) | Sep 9, 2014 | Substantially Equivalent |
| K133305 | RHYTHM VIEW WORKSTATION | Dec 16, 2013 | Substantially Equivalent |
| K130827 | FIRMAP CATHETER | Oct 31, 2013 | Substantially Equivalent |
| K110878 | RHYTHMVIEW (TM) | Sep 23, 2011 | Substantially Equivalent |