FDA 510(k) Application Details - K001213

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K001213
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 TEMECULA, CA 92589-9020 US Other 510(k) Applications for this Company
Contact	DANA HOUGHTON 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	04/14/2000
Decision Date	11/03/2000
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