FDA 510(k) Application Details - K213611

Device Classification Name	System,Test,Breath Nitric Oxide   More FDA Info for this Device
510(K) Number	K213611
Device Name	System,Test,Breath Nitric Oxide
Applicant	CAIRE Diagnostics Inc. 7020 Koll Center Parkway Suite 110 Pleasanton, CA 94566 US Other 510(k) Applications for this Company
Contact	Ryan Leard Other 510(k) Applications for this Contact
Regulation Number	862.3080   More FDA Info for this Regulation Number
Classification Product Code	MXA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2021
Decision Date	06/07/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review