510(k) K150298

Entropy Module, E-ENTROPY-01 by Ge Healthcare Filand OY — Product Code OLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 12, 2015
Date Received: February 6, 2015
Clearance Type: Traditional
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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