K970497 is an FDA 510(k) clearance for the PACE 101H. This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Sulzer Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 4, 1997, 114 days after receiving the submission on February 10, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K970497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1997 |
| Decision Date | June 04, 1997 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTE - Pulse-generator, Pacemaker, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3600 |