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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 K201339
Device Name The NOxBOXi Nitric Oxide Delivery System
Applicant
Praxair, Inc.
10 Riverview Dr.
Danbury,  CT  06810
Applicant Contact Dave Loflin
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Sarah Marie Fitzgerald
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
CCL   MRO   MRP   MRQ  
Date Received05/20/2020
Decision Date 06/19/2020
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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