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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 K233251
Device Name NOxBOXi Nitric Oxide Delivery System
Applicant
Linde Gas & Equipment, Inc.
208 W. Main St.
Livingston,  TN  38570
Applicant Contact Dave Loflin
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Brittany Dunning
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
CCL   MRO   MRP   MRQ  
Date Received09/28/2023
Decision Date 05/23/2024
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
Recalls CDRH Recalls
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