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FDA 510(k), K181861, Embrace
FDA 510(k), K181861, Embrace
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510(K) Number: K181861
Device Name: Embrace
Manufacturer: Simone Tognetti
Device Classification Name: Physiological Signal Based Seizure Monitoring System
Regulation Number: POS
Classification Product Code: 07/12/2018
Date Received: 12/20/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Embrace
Manufacturer: Simone Tognetti
Device Classification Name: Physiological Signal Based Seizure Monitoring System
Regulation Number: POS
Classification Product Code: 07/12/2018
Date Received: 12/20/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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