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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 adjunctive cardiovascular status indicator
De Novo Number DEN160020
Device Name CipherOx CRI Tablet
Requester
flashback technologies, inc.
1215 spruce st., suite 101
boulder,  CO  80302
Contact gordon van dusen
Regulation Number870.2200
Classification Product Code
PPW  
Date Received05/24/2016
Decision Date 12/21/2016
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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