Early Bird Bleed Monitoring System

Saranas, Inc.

The following data is part of a De Novo classification by Saranas, Inc. with the FDA for Early Bird Bleed Monitoring System.

Pre-market Notification Details

DeNovo IDDEN180021
Device Name:Early Bird Bleed Monitoring System
Applicant Saranas, Inc. 2450 Holcombe Blvd. Suite X Houston,  TX  77021
ContactZaffer Syed
Product CodeQFJ
DecisionGranted (DENG)
Review Advisory BoardCardiovascular
TypeDirect
Date Received2018-04-23
Decision Date2019-03-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00866532000402 DEN180021 000

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.