FDA 510(k) Application Details - K213933

Device Classification Name	Analyzer, Gas, Oxygen, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K213933
Device Name	Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant	CareOx, LLC 103 Carnegie Center, Suite 300 Princeton, NJ 08540 US Other 510(k) Applications for this Company
Contact	Young Kim Other 510(k) Applications for this Contact
Regulation Number	868.1720   More FDA Info for this Regulation Number
Classification Product Code	CCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2021
Decision Date	08/19/2022
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