FDA 510(k), K200162, Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
FDA 510(k), K200162, Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
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510(K) Number: K200162
Device Name: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Manufacturer: Yarong Liu
Device Classification Name: Electrode, Cutaneous
Regulation Number: GXY
Classification Product Code: 01/22/2020
Date Received: 04/21/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
Manufacturer: Yarong Liu
Device Classification Name: Electrode, Cutaneous
Regulation Number: GXY
Classification Product Code: 01/22/2020
Date Received: 04/21/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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