FDA 510(k) Application Details - K203827

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K203827
Device Name	Reduced- Montage Standard Electroencephalograph
Applicant	Epitel, Inc. 124 S. 400 E. Salt Lake City, UT 84111 US Other 510(k) Applications for this Company
Contact	Mark Lehmkuhle Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OMC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/29/2020
Decision Date	03/29/2021
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