FDA 510(k) Application Details - K221179

Device Classification Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K221179
Device Name	Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Applicant	Neumetry Medical Inc 47102 Mission Falls Ct. Suite 210 Fremont, CA 94539 US Other 510(k) Applications for this Company
Contact	Paul Chen 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	04/25/2022
Decision Date	09/21/2022
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