FDA 510(k) Application Details - K211153

Device Classification Name	Apparatus, Nitric Oxide Delivery   More FDA Info for this Device
510(K) Number	K211153
Device Name	Apparatus, Nitric Oxide Delivery
Applicant	Mallinckrodt Manufacturing LLC 6603 Femrite Drive Madison, WI 53718 US Other 510(k) Applications for this Company
Contact	David Trueblood 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	04/19/2021
Decision Date	04/20/2023
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