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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 K220898
Device Name NOxBOXi Nitric Oxide Delivery System
Applicant
Linde Gas & Equipment, Inc.
175 E Park Dr.
Tonawanda,  NY  14150
Applicant Contact Dave Loflin
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Olga Lewis
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
CCL   MRO   MRP   MRQ  
Date Received03/28/2022
Decision Date 04/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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