Cleared Traditional

Embrace

K181861 · Empatica S.R.L. · Neurology
Dec 2018
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K181861 is an FDA 510(k) clearance for the Embrace, a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Empatica S.R.L. (Milano, IT). The FDA issued a Cleared decision on December 20, 2018, 161 days after receiving the submission on July 12, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K181861 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2018
Decision Date December 20, 2018
Days to Decision 161 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.