FDA 510(k) Application Details - K151784

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K151784
Device Name	Device, Sleep Assessment
Applicant	CONDOR INSTRUMENTS LTDA. - EPP AVENIDA BRIGADEIRO LUIS ANTONIO, 551, CJ 124 SAO PAULO 01318-000 BR Other 510(k) Applications for this Company
Contact	RODRIGO TREVISAN OKAMOTO Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2015
Decision Date	05/25/2016
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