FDA 510(k) Application Details - K110008

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K110008
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT PITTSBURGH, PA 15239 US Other 510(k) Applications for this Company
Contact	MICHELLE BRINKER 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	01/03/2011
Decision Date	02/17/2011
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