K912084 is an FDA 510(k) clearance for the MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221. 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 July 30, 1991, 78 days after receiving the submission on May 13, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K912084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1991 |
| Decision Date | July 30, 1991 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXH — Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |