510(k) K250058

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

April 10, 2025

Date Received

January 10, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Device Class

Class II

Regulation Number

882.1400

Review Panel

NE

Submission Type

Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user