FDA 510(k) Application Details - K141353

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K141353
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	TELEFLEX MEDICAL , INC. 2917 WEEK DRIVE RESEARCH TRIANGLE PARK, NC 27709 US Other 510(k) Applications for this Company
Contact	JAMES A COCHIE Other 510(k) Applications for this Contact
Regulation Number	868.5450   More FDA Info for this Regulation Number
Classification Product Code	BTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/23/2014
Decision Date	08/01/2014
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