Class Class II
Neu Platform (K250153)
Description
Neu Platform by Neuhealth Digital , Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250153
Clearance Date2025-04-25
Clearance TypeTraditional
Product CodeGYD
Regulation Number882.1950
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250153
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. Neu Platform (K250153) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220820 | Parky App | H2o Bilisim Yazilim | 2022 |
Trace the full predicate network for K250153
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.