FDA 510(k) Application Details - K082209

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K082209
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	SUNRISE MEDICAL 100 DEVILBISS DR. SOMERSET, PA 15501 US Other 510(k) Applications for this Company
Contact	JOSEPH E OLSAVSKY Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2008
Decision Date	10/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review