Eko Foundation Analysis Software with Transformers (EFAST) (K251494)
Description
Eko Foundation Analysis Software with Transformers (EFAST) by Eko Health, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251494
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Eko Foundation Analysis Software with Transformers (EFAST) (K251494) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 |
| K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 |
Trace the full predicate network for K251494
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.