FDA 510(k) Application Details - K152664

Device Classification Name	Mechanical Ventilator   More FDA Info for this Device
510(K) Number	K152664
Device Name	Mechanical Ventilator
Applicant	New Aera, Inc. 2400 Camino Ramon, Suite 365 Ramon, CA 94583 US Other 510(k) Applications for this Company
Contact	ERIC JOHANSSON Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	ONZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2015
Decision Date	12/02/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review