FDA 510(k) Application Details - K210034

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K210034
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	EnsoData, Inc. 111 S. Hamilton St. Suite 30 Madison, WI 53703 US Other 510(k) Applications for this Company
Contact	Sigrid Schoepel Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/06/2021
Decision Date	06/16/2021
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