FDA 510(k) Application Details - K213900

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K213900
Device Name	Electroencephalograph
Applicant	WAVi Co. 3459 Ringsby Ct. Ste. #305 Denver, CO 80216 US Other 510(k) Applications for this Company
Contact	David Oakley Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/14/2021
Decision Date	05/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review