K200776 is an FDA 510(k) clearance for the Eko CORE. This device is classified as a Stethoscope, Electronic (Class II - Special Controls, product code DQD).
Submitted by Eko Devices, Inc. (Oakland, US). The FDA issued a Cleared decision on April 6, 2020, 12 days after receiving the submission on March 25, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K200776 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2020 |
| Decision Date | April 06, 2020 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQD - Stethoscope, Electronic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1875 |