FDA 510(k) Application Details - K052615

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K052615
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	MEDISIZE BV EDISONSTRAAT 1 HILLEGOM 2180 AB NL Other 510(k) Applications for this Company
Contact	SOPIHA LAM 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	09/23/2005
Decision Date	12/09/2005
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