Medical Device Manufacturer · IT , Milano

Empatica S.R.L. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2018

Recent clearances: Empatica Health Monitoring Platform for Parkinson's Disease Monitoring, EmbraceMini, EpiMonitor

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Empatica S.R.L. Neurology ✕

6 devices

1-6 of 6

Cleared Aug 14, 2026

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring

Neurology · 190d

Cleared Dec 22, 2025

Neurology · 96d

Cleared Jun 19, 2025

Neurology · 118d

Cleared CT Feb 15, 2024

Neurology · 149d

Cleared CT Dec 20, 2018

Neurology · 161d

Cleared Jan 26, 2018

Neurology · 122d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 05, 2026