K884331 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5311B A-V 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 January 10, 1989, 88 days after receiving the submission on October 14, 1988.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3630.
| 510(k) Number | K884331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1988 |
| Decision Date | January 10, 1989 |
| Days to Decision | 88 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 |