K182905 is an FDA 510(k) clearance for the UniPulse. This device is classified as a Tester, Defibrillator (Class II - Special Controls, product code DRL).
Submitted by Seaward Group (Peterlee, GB). The FDA issued a Cleared decision on December 14, 2018, 59 days after receiving the submission on October 16, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5325.
| 510(k) Number | K182905 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2018 |
| Decision Date | December 14, 2018 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRL — Tester, Defibrillator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5325 |