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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 K093922
Device Name INOMAX DS
Applicant
Ino Therapeutics
2902 Dairy Dr.
Madison,  WI  53718
Applicant Contact LARRY LEPLEY
Correspondent
Ino Therapeutics
2902 Dairy Dr.
Madison,  WI  53718
Correspondent Contact LARRY LEPLEY
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received12/22/2009
Decision Date 04/15/2010
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
Recalls CDRH Recalls
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