FDA 510(k) Application Details - K240937

Device Classification Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K240937
Device Name	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant	Inventeur, LLC 16192 Coastal Hwy Lewes, DE 19958 US Other 510(k) Applications for this Company
Contact	Tariq Chaudhry 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	04/05/2024
Decision Date	12/16/2024
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