Class Class II
SomniCheck (K223676)
Description
SomniCheck by Brainmatterz, LLC, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223676
Clearance Date2023-06-01
Clearance TypeTraditional
Product CodeGWL
Regulation Number882.1835
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223676
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. SomniCheck (K223676) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220631 | NomadAir PMU810 | Neurotronics, Inc. | 2022 |
| K040113 | SANDMAN SD20 AMPLIFIER | Eb Neuro S.P.A. | 2004 |
Trace the full predicate network for K223676
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.