510(k) K071899

BIS MODULE FOR ENVOY PATIENT MONITOR by Mennen Medical , Ltd. — Product Code OLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 22, 2007
Date Received: July 9, 2007
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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