FDA 510(k) Application Details - K192549

Device Classification Name	Reduced- Montage Standard Electroencephalograph   More FDA Info for this Device
510(K) Number	K192549
Device Name	Reduced- Montage Standard Electroencephalograph
Applicant	Byteflies NV Borsbeeksebrug 22 Floor 6 Antwerp B-2600 BE Other 510(k) Applications for this Company
Contact	Benjamin Vandendriessche 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	09/17/2019
Decision Date	06/22/2020
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