FDA 510(k) Application Details - K143127

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K143127
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	DISPO-MED (MALAYSIA) SDN BHD 21, JALAN TEKNOLOGI 3/5A, PUSAT TEKNOLOGI SINAR DAMANSARA, KOTA DAMANSARA PETALING JAYA , SELANGOR DARUL EHSAN 47810 MY Other 510(k) Applications for this Company
Contact	NC LEOW 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	10/31/2014
Decision Date	02/13/2015
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