FDA 510(k) Application Details - K201206

Device Classification Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K201206
Device Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant	Carrot Inc. 1400A Seaport Blvd, Suite 501 Redwood City, CA 94063 US Other 510(k) Applications for this Company
Contact	Sara Lippert Other 510(k) Applications for this Contact
Regulation Number	868.1430   More FDA Info for this Regulation Number
Classification Product Code	CCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2020
Decision Date	06/30/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review