Class Class II
Okti (K230073)
Description
Okti by Compumedics Limited, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230073
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeGWQ
Regulation Number882.1400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230073
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. Okti (K230073) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K093223 | COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG | Compumedics Limited | 2010 |
Trace the full predicate network for K230073
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.