K083347 is an FDA 510(k) clearance for the IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS. This device is classified as a Tester, Defibrillator (Class II - Special Controls, product code DRL).
Submitted by Fluke Biomedical (Orange, US). The FDA issued a Cleared decision on December 24, 2008, 41 days after receiving the submission on November 13, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5325.
| 510(k) Number | K083347 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2008 |
| Decision Date | December 24, 2008 |
| Days to Decision | 41 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 |