K903960 is an FDA 510(k) clearance for the MODEL 9444 TELETRACE II ECG MONITORING SYSTEM. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 9, 1990, 42 days after receiving the submission on August 28, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K903960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1990 |
| Decision Date | October 09, 1990 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXH — Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |