FDA 510(k) Application Details - K082982

Device Classification Name	Mechanical Ventilator   More FDA Info for this Device
510(K) Number	K082982
Device Name	Mechanical Ventilator
Applicant	BREATHE TECHNOLOGIES, INC. 1193 SHERMAN ST. ALAMEDA, CA 94501 US Other 510(k) Applications for this Company
Contact	CRAIG COOMBS 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	10/06/2008
Decision Date	07/20/2009
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