510(k) K202588

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

December 7, 2020

Date Received

September 8, 2020

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Normalizing Quantitative Electroencephalograph Software

Device Class

Class II

Regulation Number

882.1400

Review Panel

NE

Submission Type

Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.