Class Class II
Nicolet EDX (K243982)
Description
Nicolet EDX by Natus Neurology Incorporated, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243982
Clearance Date2025-01-22
Clearance TypeSpecial
Product CodeGWF
Regulation Number882.1870
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243982
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. Nicolet EDX (K243982) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024 |
| K232285 | U-Lite PRO | Sonoscanner Sarl | 2024 |
| K120979 | CAREFUSION NICOLET EDX | Carefusion 209, Inc. | 2012 |
Trace the full predicate network for K243982
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.