K810657 is an FDA 510(k) clearance for the TEMPTRON #'S 6804/6805. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on April 8, 1981, 28 days after receiving the submission on March 11, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K810657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1981 |
| Decision Date | April 08, 1981 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |