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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 K193481
Device Name AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
Applicant
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Applicant Contact Amy Pieper
Correspondent
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact Amy Pieper
Regulation Number868.5165
Classification Product Code
MRN  
Date Received12/17/2019
Decision Date 03/10/2020
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
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