K200849 is an FDA 510(k) clearance for the Tempus LS - Manual. This device is classified as a Dc-defibrillator, Low-energy, (including Paddles) (Class II - Special Controls, product code LDD).
Submitted by Remote Diagnostic Technologies, Ltd. A Philips Company (Basingstoke, GB). The FDA issued a Cleared decision on July 24, 2020, 115 days after receiving the submission on March 31, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5300.
| 510(k) Number | K200849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2020 |
| Decision Date | July 24, 2020 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDD - Dc-defibrillator, Low-energy, (including Paddles) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5300 |