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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name system, test, breath nitric oxide
De Novo Number DEN030001
510(K) Number K021133
Device Name NIOX ARTICLE NO: 02-1000
Requester
aerocrine ab
16787 bernardo center dr.
suite a-1
san diego,  CA  92128
Contact sean m curry
Regulation Number862.3080
Classification Product Code
MXA  
Date Received03/18/2003
Decision Date 04/30/2003
Decision granted (DENG)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
Reclassification Order Reclassification Order
Type Post-NSE
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