FDA 510(k) Application Details - K160112

Device Classification Name	Attachment, Breathing, Positive End Expiratory Pressure   More FDA Info for this Device
510(K) Number	K160112
Device Name	Attachment, Breathing, Positive End Expiratory Pressure
Applicant	BESMED HEALTH BUSINESS CORP. NO.5, LANE 116, WU-KONG 2ND RD NEW TAIPEI CITY TW Other 510(k) Applications for this Company
Contact	ERIC LI 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	01/19/2016
Decision Date	04/29/2016
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