K213794 is an FDA 510(k) clearance for the Eko Murmur Analysis Software (EMAS). 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 June 29, 2022, 205 days after receiving the submission on December 6, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K213794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2021 |
| Decision Date | June 29, 2022 |
| Days to Decision | 205 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 |