Cleared Traditional

EpiMonitor

K232915 · Empatica S.R.L. · Neurology
Feb 2024
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K232915 is an FDA 510(k) clearance for the EpiMonitor, a Physiological Signal Based Seizure Monitoring System (Class II — Special Controls, product code POS), submitted by Empatica S.R.L. (Milan, IT). The FDA issued a Cleared decision on February 15, 2024, 149 days after receiving the submission on September 19, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1580.

Submission Details

510(k) Number K232915 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2023
Decision Date February 15, 2024
Days to Decision 149 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.