FDA 510(k) Application Details - K020900

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K020900
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	SUNRISE MEDICAL HHG, INC. 100 DEVILBISS DR. SOMERSET, PA 15501 US Other 510(k) Applications for this Company
Contact	JOE MITCHELL 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	03/20/2002
Decision Date	06/03/2002
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	Y
Expedited Review