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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 K171696
Device Name NOxBOXi Nitric Oxide Delivery System
Applicant
Praxair Distribution, Inc.
10 Riverview Dr.
Danbury,  CT  06810
Applicant Contact Michael E. Skrjanc
Correspondent
Praxair Distribution, Inc.
10 Riverview Dr.
Danbury,  CT  06810
Correspondent Contact Michael E. Skrjanc
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
CCL   MRO   MRP   MRQ  
Date Received06/07/2017
Decision Date 10/02/2018
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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