Tempus LS - Manual
FDA 510(k) clearance K200849 · decided 2020-07-24
Clearance details
- K-number
- K200849
- Device name
- Tempus LS - Manual
- Applicant
- Remote Diagnostic Technologies, Ltd. A Philips Company
- Decision
- Substantially Equivalent
- Date received
- 2020-03-31
- Decision date
- 2020-07-24
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- LDD
- Device class
- 2
- Regulation number
- 870.5300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Basingstoke, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that recall (Z-0557-2025) | Remote Diagnostic Technologies Ltd. | 2024-11-26 |
| Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual U recall (Z-2028-2024) | Remote Diagnostic Technologies Ltd. | 2024-06-06 |
| Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 recall (Z-1825-2023) | Remote Diagnostic Technologies Ltd. | 2023-06-12 |
| Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product recall (Z-0564-2021) | Remote Diagnostic Technologies Ltd. | 2020-12-11 |