Company ยท US
Eko Devices, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 2023 | K230111 | CORE 500 Digital Stethoscope Eko Devices, Inc. | DQD |
| Jun 29, 2022 | K213794 | Eko Murmur Analysis Software (EMAS) Eko Devices, Inc. | DQD |
| Apr 6, 2020 | K200776 | Eko CORE Eko Devices, Inc. | DQD |
| Jan 15, 2020 | K192004 | Eko Analysis Software Eko Devices, Inc. | MWI |
| May 19, 2017 | K170874 | Eko Model E5 System (EME5), Eko DUO Eko Devices, Inc. | DQD |
| Aug 28, 2015 | K151319 | Eko Electronic Stethoscope System Eko Devices, Inc. | DQD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||