K821434 is an FDA 510(k) clearance for the EKG (ECG) ELECTRODES. This device is classified as a Electrode, Electrocardiograph (Class II - Special Controls, product code DRX).
Submitted by Dupaco, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982, 79 days after receiving the submission on May 12, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2360.
| 510(k) Number | K821434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1982 |
| Decision Date | July 30, 1982 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRX — Electrode, Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2360 |