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

Empatica S.R.L. has 8 FDA 510(k) cleared medical devices. Based in Milano, IT.

Latest FDA clearance: Dec 2025. Active since 2018. Primary specialty: Neurology.

Browse the FDA 510(k) cleared devices submitted by Empatica S.R.L. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Rakesh Lal as regulatory consultant. 4 devices have linked clinical trials registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.