K941404 is an FDA 510(k) clearance for the IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER. This device is classified as a Tester, Defibrillator (Class II - Special Controls, product code DRL).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on June 29, 1994, 98 days after receiving the submission on March 23, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5325.
| 510(k) Number | K941404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1994 |
| Decision Date | June 29, 1994 |
| Days to Decision | 98 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 |