FDA 510(k) Application Details - K220898

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K220898
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	Linde Gas & Equipment Inc. 175 E Park Drive Tonawanda, NY 14150 US Other 510(k) Applications for this Company
Contact	Dave Loflin 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	03/28/2022
Decision Date	04/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review