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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 K253095
Device Name ULSPIRA TS™ Nitric Oxide Therapy System
Applicant
Airgas Therapeutics, LLC
6141 Easton Rd., P.O. Box 310
Plumsteadville,  PA  18949
Applicant Contact Timothy Warren
Correspondent
Drug Device Consulting
13014 N. Dale Mabry Hwy., #326
Tampa,  FL  33618
Correspondent Contact Mikel Alberdi
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
CCL   MRO   MRP   MRQ  
Date Received09/23/2025
Decision Date 10/30/2026
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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