Embrace

Physiological Signal Based Seizure Monitoring System

Empatica Srl

The following data is part of a premarket notification filed by Empatica Srl with the FDA for Embrace.

Pre-market Notification Details

• Device ID: K181861
• 510k Number: K181861
• Device Name: Embrace
• Classification: Physiological Signal Based Seizure Monitoring System
• Applicant: Empatica Srl Via Stendhal 36 Milano, IT 20144
• Contact: Simone Tognetti
• Correspondent: Rakesh Lal; Rakesh Lal 318 Rindge Ave 407 Cambridge, MA 02140
• Product Code: POS
• CFR Regulation Number: 882.1580 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-12
• Decision Date: 2018-12-20
• Summary: summary