Class Class II
NEBA® Compact EEG2R Mobile Headset (K223628)
Description
NEBA® Compact EEG2R Mobile Headset by Neba Health, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223628
Clearance Date2023-03-02
Clearance TypeTraditional
Product CodeOMC
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223628
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. NEBA® Compact EEG2R Mobile Headset (K223628) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203827 | REMI | Epitel, Inc. | 2021 |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 |
Trace the full predicate network for K223628
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.