K161302 is an FDA 510(k) clearance for the PC ECG. 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 July 1, 2016, 53 days after receiving the submission on May 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K161302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2016 |
| Decision Date | July 01, 2016 |
| Days to Decision | 53 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 |