Class Class II
Tinnitogram Signal Generator (K221168)
Description
Tinnitogram Signal Generator by Goldenear Company, Inc., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221168
Clearance Date2023-02-01
Clearance TypeTraditional
Product CodeKLW
Regulation Number874.3400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221168
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. Tinnitogram Signal Generator (K221168) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K151719 | REVE134 | Kw Ear Lab, Inc. | 2015 |
Trace the full predicate network for K221168
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.