FDA 510(k) Application Details - K122610

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K122610
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	SEN MU TECHNOLOGY CO., LTD. NO. 15-2, LANE 26, MINCYUAN 1SR RD LINGYA DISTRICT KAOHSIUNG CITY 802 TW Other 510(k) Applications for this Company
Contact	MING-YIE JN, PH.D. Other 510(k) Applications for this Contact
Regulation Number	868.5965   More FDA Info for this Regulation Number
Classification Product Code	BYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2012
Decision Date	08/05/2013
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