FDA 510(k) Application Details - K143150

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K143150
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	BESMED HEALTH BUSINESS CORP. NO.5, LANE116, WU-KONG 2ND RD NEW TAIPEI CITY TAIWAN TW Other 510(k) Applications for this Company
Contact	WINNIE CHUNG Other 510(k) Applications for this Contact
Regulation Number	868.1400   More FDA Info for this Regulation Number
Classification Product Code	CCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2014
Decision Date	02/05/2015
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