FDA 510(k) Application Details - K231823

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K231823
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	Linde Gas & Equipment Inc. 208 W Main St. Livingston, TN 38570 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	06/21/2023
Decision Date	08/11/2023
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