The following data is part of a premarket notification filed by Eko Devices, Inc. with the FDA for Eko Core.
| Device ID | K200776 |
| 510k Number | K200776 |
| Device Name: | Eko CORE |
| Classification | Stethoscope, Electronic |
| Applicant | Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 |
| Contact | Arezou Azar |
| Correspondent | Arezou Azar 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 | 2020-03-25 |
| Decision Date | 2020-04-06 |