K073230 is an FDA 510(k) clearance for the MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS. 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 20, 2007, 35 days after receiving the submission on November 15, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3720.
| 510(k) Number | K073230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2007 |
| Decision Date | December 20, 2007 |
| Days to Decision | 35 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 |