Devices · Empatica Srl

EpiMonitor

Empatica Srl is listed for EpiMonitor (K232915). The FDA list gives February 15, 2024 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code POS as “Physiological Signal Based Seizure Monitoring System”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232915

Official FDA database record

Date of final decision

February 15, 2024

Company on the FDA list

Empatica Srl

Lead panel

Neurology

Primary product code

POS

openFDA device name for the code

Physiological Signal Based Seizure Monitoring System

Device class

2

Regulation number

882.1580

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary