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510(k) K200276

Device
SPEAC System
Applicant
Brain Sentinel, Inc.
510(k) number
K200276
Product code
POS  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-06
Date received
2020-02-04
Regulation
882.1580
Classification name
Physiological Signal Based Seizure Monitoring System
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Richard Waite
Address
8023 Vantage Dr., Suite 216 San Antonio TX US 78230 78230

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code POS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251506Nelli (Version 7.11)Neuro Event Labs OY2025-11-21
K243199NightWatch+ USLivassured BV2025-07-12
K250515EpiMonitorEmpatica S.r.l.2025-06-19
K243515EpiWatch Monitoring SystemEpiwatch, Inc.2025-03-07
K232915EpiMonitorEmpatica S.r.l.2024-02-15
K182180SPEAC SystemBrain Sentinel, Inc.2019-05-11
K181861EmbraceEmpatica S.r.l.2018-12-20
K172935EmbraceEmpatica S.r.l.2018-01-26
DEN140033CompanionLgch, Inc.2017-02-16

Legacy Summary#

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FDA Review#

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