FDA 510(k) Application Details - K062664

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K062664
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	APEX MEDICAL CORP. NO. 9, MINSHENG STREET TUCHENG CITY, TAIPEI COUNTY 236 TW Other 510(k) Applications for this Company
Contact	ALAN CHANG 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	09/07/2006
Decision Date	12/06/2006
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