Cleared Traditional

SPEAC System

K182180 · Brain Sentinel, Inc. · Neurology
May 2019
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K182180 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 May 11, 2019, 271 days after receiving the submission on August 13, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K182180 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2018
Decision Date May 11, 2019
Days to Decision 271 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.