Medical Device Manufacturer · IT , Milano

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

8 submissions · 8 cleared · Since 2018
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Empatica S.R.L. Neurology ✕
5 devices
1-5 of 5
Cleared Dec 22, 2025
EmbraceMini
K252981 · LEL
Neurology · 96d
Cleared Jun 19, 2025
EpiMonitor
K250515 · POS
Neurology · 118d
Cleared CT Feb 15, 2024
EpiMonitor
K232915 · POS
Neurology · 149d
Cleared Dec 20, 2018
Embrace
K181861 · POS
Neurology · 161d
Cleared Jan 26, 2018
Embrace
K172935 · POS
Neurology · 122d
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All8 Neurology 5 Cardiovascular 2 Anesthesiology 1