FDA 510(k) Application Details - K213007

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K213007
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	Cerebra Medical Ltd. 1470 Wilson Place Unit B Winnipeg R3T2N9 CA Other 510(k) Applications for this Company
Contact	Sharon Cholowsky Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2021
Decision Date	07/06/2022
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