K023205 is an FDA 510(k) clearance for the ELOX P 45-BP. This device is classified as a Permanent Pacemaker Electrode (Class III - Premarket Approval, product code DTB).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 24, 2003, 211 days after receiving the submission on September 25, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K023205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | September 25, 2002 |
| Decision Date | April 24, 2003 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTB — Permanent Pacemaker Electrode |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 870.3680 |