K821384 is an FDA 510(k) clearance for the EXERCISE ECG ELECTRODES, REUSABLE. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Respironics, Inc. (Monroeville, US). The FDA issued a Cleared decision on June 17, 1982, 38 days after receiving the submission on May 10, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K821384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1982 |
| Decision Date | June 17, 1982 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |