510(k) DEN140033

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.