Class Class II
Delphi Stimulator (K242345)
Description
Delphi Stimulator by Quantalx Neuroscience, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242345
Clearance Date2024-11-05
Clearance TypeTraditional
Product CodeGWF
Regulation Number882.1870
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242345
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. Delphi Stimulator (K242345) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160280 | MagPro R20 | Tonica Elektronik A/S | 2016 |
Trace the full predicate network for K242345
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.