Class Class II
Disposable Non-invasive EEG Sensor (K220448)
Description
Disposable Non-invasive EEG Sensor by Shenzhen Med-Link Electronics Tech Co., Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220448
Clearance Date2023-01-19
Clearance TypeTraditional
Product CodeGXY
Regulation Number882.1320
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220448
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. Disposable Non-invasive EEG Sensor (K220448) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K143506 | BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENS... | Covidien | 2015 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240668 | Amydi-med Disposable Non-invasive EEG electrodes | Shenzhen Amydi-Med Electrics Tech C... | 2024 |
Trace the full predicate network for K220448
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.