K033613 is an FDA 510(k) clearance for the MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER. This device is classified as a Tester, Pacemaker Electrode Function (Class II - Special Controls, product code DTA).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 8, 2003, 21 days after receiving the submission on November 17, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3720.
| 510(k) Number | K033613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2003 |
| Decision Date | December 08, 2003 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTA — Tester, Pacemaker Electrode Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3720 |