K212278 is an FDA 510(k) clearance for the Electrocardiograph. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on April 7, 2022, 261 days after receiving the submission on July 20, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K212278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2021 |
| Decision Date | April 07, 2022 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |