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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 K143213
Device Name INOmax DSIR Plus MRI
Applicant
INO Therapeutics/Ikaria
6603 Femrite Drive
Madison,  WI  53718
Applicant Contact Robert Bovy
Correspondent
INO Therapeutics/Ikaria
6603 Femrite Drive
Madison,  WI  53718
Correspondent Contact Robert Bovy
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received11/10/2014
Decision Date 07/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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