Brain Sentinel Inc

FDA Filings

This page includes the latest FDA filings for Brain Sentinel Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012995918
FEI Number3012995918
NameBRAIN SENTINEL INC.
Owner & OperatorBrain Sentinel Inc.
Contact Address8023 Vantage Dr 216
San Antonio TX 78230 US
Official Correspondent
  • Richard Waite
  • 1-214-6629277-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8023 Vantage Dr Ste 216
San Antonio, TX 78230 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Brain Sentinel, Inc.
SPEAC System2021-02-06
BRAIN SENTINEL, INC.
 AccuSense Sensitive Electrode Patch SPC15-90055 EU SPC15-900552019-11-15
BRAIN SENTINEL, INC.
 AccuSense Sensitive Electrode Patch-SPC15-90054 US SPC15-90054 2019-11-15
BRAIN SENTINEL INC.
SPEAC System2019-10-16
BRAIN SENTINEL, INC.
 SPEAC System Assy, Mini Monitor, EU SPC15-900582019-09-13
Brain Sentinel, Inc.
SPEAC System2019-05-11
BRAIN SENTINEL, INC.
 SPEAC System 2018-07-06
BRAIN SENTINEL INC.
SPEAC System2017-03-17

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