FDA 510(k), K172935, Embrace
FDA 510(k), K172935, Embrace
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K172935
Device Name: Embrace
Manufacturer: Simone Tognetti
Device Classification Name: Physiological Signal Based Seizure Monitoring System
Regulation Number: POS
Classification Product Code: 09/26/2017
Date Received: 01/26/2018
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: 09/26/2017
Date Received: 01/26/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
- 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.
View full details