FDA 510(k) Application Details - K093617

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K093617
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	VENTLAB CORP. 155 BOYCE DRIVE MOCKSVILLE, NC 27028 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	11/23/2009
Decision Date	01/27/2011
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