The following data is part of a premarket notification filed by Eko Devices, Inc. with the FDA for Eko Model E5 System (eme5), Eko Duo.
| Device ID | K170874 |
| 510k Number | K170874 |
| Device Name: | Eko Model E5 System (EME5), Eko DUO |
| Classification | Stethoscope, Electronic |
| Applicant | Eko Devices, Inc. 2600 10th St, Suite 260 Berkeley, CA 94710 |
| Contact | Connor Landgraf |
| Correspondent | Michael Righter Righter Consulting Group, LLC PO Box 63 Tolovana Park, OR 97145 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-24 |
| Decision Date | 2017-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863609000327 | K170874 | 000 |