FDA 510(k) Application Details - K071958

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K071958
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	SMITHS MEDICAL ASD, INC. 160 WEYMOUTH ST. ROCKLAND, MA 02370 US Other 510(k) Applications for this Company
Contact	CHRISTINE LLOYD 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	07/16/2007
Decision Date	11/21/2007
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