K964190 is an FDA 510(k) clearance for the ERA 300 DUAL CHAMBER 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 July 10, 1997, 262 days after receiving the submission on October 21, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K964190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1996 |
| Decision Date | July 10, 1997 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| 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 |