Empatica Srl

Name: AI Device Index: FDA-listed AI-enabled medical devices
Creator: AI Device Index
License: https://creativecommons.org/licenses/by/4.0/

3 AI-enabled medical devices from Empatica Srl on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

Decision	Number	Device	Company	Panel
2025-06-19	K250515	EpiMonitor	Empatica Srl	Neurology
2024-02-15	K232915	EpiMonitor	Empatica Srl	Neurology
2018-12-20	K181861	Embrace	Empatica Srl	Neurology

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