FDA 510(k) Application Details - K090113

Device Classification Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use   More FDA Info for this Device
510(K) Number	K090113
Device Name	Ventilator, Continuous, Minimal Ventilatory Support,Facility Use
Applicant	BREAS MEDICAL AB FORETAGSVAGEN 1 MOLNLYCKE 435 33 SE Other 510(k) Applications for this Company
Contact	BIRGITTA BOLANDER Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/21/2009
Decision Date	05/14/2009
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