Class Class II
BrainView QEEG Software (K212684)
Description
BrainView QEEG Software by Medeia, Inc., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK212684
Clearance Date2023-01-28
Clearance TypeTraditional
Product CodeOLU
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K212684
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. BrainView QEEG Software (K212684) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171414 | qEEG-Pro | Brainmaster Technologies, Inc. | 2018 |
| K041263 | NEUROGUIDE ANALYSIS SYSTEM | Applied Neuroscience, Inc. | 2004 |
Trace the full predicate network for K212684
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.