FDA 510(k) Application Details - K183394

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K183394
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki FI-00510 FI Other 510(k) Applications for this Company
Contact	Joel Kent 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	12/07/2018
Decision Date	05/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review