Class Class II
Cumulus Functional Neurophysiology Platform (K221963)
Description
Cumulus Functional Neurophysiology Platform by Cumulus Neuroscience Limited, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221963
Clearance Date2023-04-27
Clearance TypeTraditional
Product CodeGWQ
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221963
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. Cumulus Functional Neurophysiology Platform (K221963) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192753 | NeuralScan System | Medeia, Inc. | 2020 |
Trace the full predicate network for K221963
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.