FDA 510(k) Application Details - K103578

Device Classification Name	Spirometer, Monitoring (W/Wo Alarm)   More FDA Info for this Device
510(K) Number	K103578
Device Name	Spirometer, Monitoring (W/Wo Alarm)
Applicant	RESPIRONICS NOVAMETRIX, LLC 5 TECHNOLOGY DRIVE WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	KEVIN MADER Other 510(k) Applications for this Contact
Regulation Number	868.1850   More FDA Info for this Regulation Number
Classification Product Code	BZK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2010
Decision Date	06/02/2011
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