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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 K131686
Device Name INOMAX DSIR (DELIVERY SYSTEM)
Applicant
INO THERAPEUTICS/IKARIA
2902 DAIRY DRIVE
MADISON,  WI  53718
Applicant Contact ROBERT BOVY
Correspondent
INO THERAPEUTICS/IKARIA
2902 DAIRY DRIVE
MADISON,  WI  53718
Correspondent Contact ROBERT BOVY
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRP   MRQ  
Date Received06/10/2013
Decision Date 11/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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