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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Nitric Oxide Delivery
510(k) Number K212409
Device Name Ulspira TS Nitric Oxide Therapy System
Applicant
Airgas Therapeutics
12800 W. Little York Rd.
Houston,  TX  77041
Applicant Contact Steven Miller
Correspondent
Airgas Therapeutics
12800 W. Little York Rd.
Houston,  TX  77041
Correspondent Contact Steven Miller
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
CCL   MRO   MRP   MRQ  
Date Received08/03/2021
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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