K914974 is an FDA 510(k) clearance for the MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 19, 1991, 43 days after receiving the submission on November 6, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K914974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1991 |
| Decision Date | December 19, 1991 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |