SPEAC System

Physiological Signal Based Seizure Monitoring System

Brain Sentinel, Inc.

The following data is part of a premarket notification filed by Brain Sentinel, Inc. with the FDA for Speac System.

Pre-market Notification Details

Device IDK200276
510k NumberK200276
Device Name:SPEAC System
ClassificationPhysiological Signal Based Seizure Monitoring System
Applicant Brain Sentinel, Inc. 8023 Vantage Drive Suite 216 San Antonio,  TX  78230
ContactRichard Waite
CorrespondentRichard Waite
Brain Sentinel, Inc. 8023 Vantage Drive Suite 216 San Antonio,  TX  78230
Product CodePOS  
CFR Regulation Number882.1580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2021-02-06

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