Class Class II
REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408)
Description
REMI-AI Rapid Detection Module (REMI-AI RDM) by Epitel, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240408
Clearance Date2024-10-17
Clearance TypeTraditional
Product CodeOMB
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240408
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. REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231779 | REMI AI Discrete Detection Module | Epitel, Inc. | 2024 |
| K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2019 |
Trace the full predicate network for K240408
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.