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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 K101034
Device Name NIOX MINO MODEL 09-1000
Applicant
Aerocrine AB
Sundbybergsvagen 9
P.O. Box 1024
Solna,  SE SE-17121
Applicant Contact JOHANNA KARLING
Correspondent
Aerocrine AB
Sundbybergsvagen 9
P.O. Box 1024
Solna,  SE SE-17121
Correspondent Contact JOHANNA KARLING
Regulation Number862.3080
Classification Product Code
MXA  
Date Received04/14/2010
Decision Date 09/02/2010
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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