TEMPUS PRO PATIENT MONITOR
FDA 510(k) clearance K130773 · decided 2013-06-05
Clearance details
- K-number
- K130773
- Device name
- TEMPUS PRO PATIENT MONITOR
- Applicant
- Remote Diagnostic Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-03-20
- Decision date
- 2013-06-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MWI
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hampshire, GB
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset recall (Z-1666-2025) | Remote Diagnostic Technologies Ltd. | 2025-04-24 |