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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 intravascular bleed monitor
De Novo Number DEN180021
Device Name Early Bird Bleed Monitoring System
Saranas, Inc.
2450 holcombe blvd. suite x
houston,  TX  77021
Contact zaffer syed
Regulation Number870.1345
Classification Product Code
Date Received04/23/2018
Decision Date 03/01/2019
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct