FDA 510(k) Application Details - K243956

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K243956
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo 161-8560 JP Other 510(k) Applications for this Company
Contact	Sandra Gadeyne 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	12/23/2024
Decision Date	06/10/2025
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