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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 Dr.
Madison,  WI  53718
Applicant Contact Robert Bovy
Correspondent
Ino Therapeutics/Ikaria
6603 Femrite Dr.
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
Predetermined Change
Control Plan Authorized		 No
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