K042708 is an FDA 510(k) clearance for the ERA 3000 PACING SYSTEM ANALYZER. This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 20, 2004, 20 days after receiving the submission on September 30, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K042708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2004 |
| Decision Date | October 20, 2004 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTE — Pulse-generator, Pacemaker, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3600 |