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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Breath Nitric Oxide
510(k) Number K083617
Device Name APIERON INSIGHT ENO SYSTEM
Applicant
Apieron, Inc.
155 Jefferson Dr.
Menlo Park,  CA  94025
Applicant Contact NINA PELED
Correspondent
Apieron, Inc.
155 Jefferson Dr.
Menlo Park,  CA  94025
Correspondent Contact NINA PELED
Regulation Number862.3080
Classification Product Code
MXA  
Date Received12/08/2008
Decision Date 01/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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