TEMPUS PRO WITH ENHANCED FEATURES
FDA 510(k) clearance K133973 · decided 2014-08-14
Clearance details
- K-number
- K133973
- Device name
- TEMPUS PRO WITH ENHANCED FEATURES
- Applicant
- Remote Diagnostic Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-26
- Decision date
- 2014-08-14
- Days to decision
- 231 days
- Clearance type
- Abbreviated
- Product code
- QYW
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Basingstoke, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEARTRAC ECG MONITORING SYSTEM (K934913) | Cardiac Telecom Corp. | 1995-06-05 |
Recalls involving this device
No recalls on record reference this clearance.