FDA 510(k) Application Details - K100528

Device Classification Name	Mechanical Ventilator   More FDA Info for this Device
510(K) Number	K100528
Device Name	Mechanical Ventilator
Applicant	BREATHE TECHNOLOGIES, INC. 4000 EXECUTIVE PARKWAY, SUITE 190 SAN RAMON, CA 94583 US Other 510(k) Applications for this Company
Contact	SUZON LOMMEL 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	02/24/2010
Decision Date	04/23/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review