Cleared Traditional

SPEAC System

K200276 · Brain Sentinel, Inc. · Neurology
Feb 2021
Decision
368d
Days
Class 2
Risk

About This 510(k) Submission

K200276 is an FDA 510(k) clearance for the SPEAC System, a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Brain Sentinel, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 6, 2021, 368 days after receiving the submission on February 4, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K200276 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2020
Decision Date February 06, 2021
Days to Decision 368 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code POS — Physiological Signal Based Seizure Monitoring System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1580
Definition The Physiological Signal Based Seizure Monitoring System Is A Prescription Device That Uses Physiological Signal To Identify Abnormal Physiological Activity That May Be Associated With A Seizure. The System Does Not Predict Seizure Onsets, And Is Not Intended As A Standalone Seizure Monitoring Device.