K190437 is an FDA 510(k) clearance for the Delta 3300. This device is classified as a Tester, Defibrillator (Class II - Special Controls, product code DRL).
Submitted by Netech Corporation (Farmingdale, US). The FDA issued a Cleared decision on August 28, 2019, 187 days after receiving the submission on February 22, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5325.
| 510(k) Number | K190437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2019 |
| Decision Date | August 28, 2019 |
| Days to Decision | 187 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 |