FDA 510(k) Application Details - K132857

Device Classification Name	Humidifier, Respiratory Gas, (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K132857
Device Name	Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant	PACIFIC MEDICO CO., LTD. 2-6-4 HONGO BUNKYO-KU, TOKYO 113-0033 JP Other 510(k) Applications for this Company
Contact	YOSHIO TOYAMA 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	09/12/2013
Decision Date	05/01/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review