FDA 510(k) Application Details - K212409

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K212409
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	Airgas Therapeutics 12800 West Little York Road Houston, TX 77041 US Other 510(k) Applications for this Company
Contact	Steven Miller Other 510(k) Applications for this Contact
Regulation Number	868.5165   More FDA Info for this Regulation Number
Classification Product Code	MRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2021
Decision Date	06/30/2023
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