K921164 is an FDA 510(k) clearance for the MODEL 1300 SOFTRACE II ELECTRODE. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Medtronic Vascular (Haverhill, US). The FDA issued a Cleared decision on March 18, 1993, 372 days after receiving the submission on March 11, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K921164 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1992 |
| Decision Date | March 18, 1993 |
| Days to Decision | 372 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRX — Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |