K831768 is an FDA 510(k) clearance for the EXTERNAL PULSE GENERATOR FOR TEMP. STIM. This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 16, 1983, 198 days after receiving the submission on June 1, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K831768 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1983 |
| Decision Date | December 16, 1983 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DTE - Pulse-generator, Pacemaker, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3600 |