FDA 510(k) Application Details - K121975

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K121975
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	FISHER & PAYKEL HEALTHCARE, LTD. 15 MAURICE PAYKEL PLACE EAST TAMAKI ACKLAND 2013 NZ Other 510(k) Applications for this Company
Contact	BRETT WHISTON 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	07/05/2012
Decision Date	01/03/2013
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