510(k) DEN140033
DEN140033 is an FDA 510(k) premarket notification submitted by Lgch, Inc. for the device "Companion". The FDA issued a decision of De Novo Granted on February 16, 2017. The device falls under product code POS (Physiological Signal Based Seizure Monitoring System), a Class II device regulated under 21 CFR 882.1580.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 16, 2017
- Date Received
- November 10, 2014
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Physiological Signal Based Seizure Monitoring System
- Device Class
- Class II
- Regulation Number
- 882.1580
- Review Panel
- NE
- Submission Type
The Physiological signal based seizure monitoring system is a prescription device that uses physiological signal to identify abnormal physiological activity that may be associated with a seizure. The System does not predict seizure onsets, and is not intended as a standalone seizure monitoring device.