510(k) K033999

SEDLINE WITH FRONTAL PSI by Physiometrix, Inc. — Product Code OLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 6, 2004
Date Received: December 24, 2003
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Index-Generating Electroencephalograph Software
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

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