FDA 510(k) Application Details - K050990

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K050990
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	MEDICAL INDUSTRIES AMERICA, INC. 2636 289TH PLACE ADEL, IA 50003-8021 US Other 510(k) Applications for this Company
Contact	KEITH THEISEN 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	04/19/2005
Decision Date	05/02/2005
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	Y
Expedited Review