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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 image processing device for estimation of external blood loss
De Novo Number DEN130015
510(K) Number K130190
Device Name PIXEL 3 SYSTEM
Requester
GAUSS SURGICAL, INC.
334 state st., suite 201
los altos,  CA  94022
Contact peggy mclaughlin
Regulation Number880.2750
Classification Product Code
PBZ  
Date Received02/04/2013
Decision Date 05/09/2014
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General & Plastic Surgery
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
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