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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
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