The following data is part of a premarket notification filed by Eko Devices, Inc. with the FDA for Eko Electronic Stethoscope System.
| Device ID | K151319 |
| 510k Number | K151319 |
| Device Name: | Eko Electronic Stethoscope System |
| 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 | 2015-05-18 |
| Decision Date | 2015-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863609000310 | K151319 | 000 |
| 00863609000303 | K151319 | 000 |
| 00850010298016 | K151319 | 000 |
| 00850010298009 | K151319 | 000 |