FDA 510(k) Application Details - K060546

Device Classification Name	Ventilator, Continuous, Non-Life-Supporting   More FDA Info for this Device
510(K) Number	K060546
Device Name	Ventilator, Continuous, Non-Life-Supporting
Applicant	BREAS MEDICAL AB FORETAGSVAGEN 1 MOLNLYCKE, VASTRA GOTALAND SE-435 33 SE Other 510(k) Applications for this Company
Contact	KARL-JOHAN HOLM Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	MNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2006
Decision Date	05/26/2006
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