The following data is part of a premarket notification filed by Eko Devices, Inc. with the FDA for Eko Murmur Analysis Software (emas).
| Device ID | K213794 |
| 510k Number | K213794 |
| Device Name: | Eko Murmur Analysis Software (EMAS) |
| Classification | Stethoscope, Electronic |
| Applicant | Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 |
| Contact | Sam Huang |
| Correspondent | Sam Huang Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-06 |
| Decision Date | 2022-06-29 |