K955829 is an FDA 510(k) clearance for the SAFPACE SYSTEM. This device is classified as a Electrode, Pacemaker, Temporary (Class II - Special Controls, product code LDF).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 18, 1997, 693 days after receiving the submission on December 26, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3680.
| 510(k) Number | K955829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1995 |
| Decision Date | November 18, 1997 |
| Days to Decision | 693 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LDF — Electrode, Pacemaker, Temporary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3680 |