K850077 is an FDA 510(k) clearance for the MEDTRONIC 5311 PACING SYSTEM ANALYZER. This device is classified as a Analyzer, Pacemaker Generator Function (Class II - Special Controls, product code DTC).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on July 16, 1985, 188 days after receiving the submission on January 9, 1985.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3630.
| 510(k) Number | K850077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1985 |
| Decision Date | July 16, 1985 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTC — Analyzer, Pacemaker Generator Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3630 |