510(k) K062613

BIS EEG MONITOR VIEW by Aspect Medical Systems, Inc. — Product Code OLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 18, 2007
Date Received: September 5, 2006
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.

Other clearances by Aspect Medical Systems, Inc.

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K062692 — BIS BILATERAL SENSOR (December 13, 2006)
K052981 — BIS EEG MONITOR, MODEL BISX4 (November 1, 2005)
K052362 — BIS EEG MONITOR, MODEL A-3000 (September 9, 2005)
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K041670 — BIS PEDIATRIC SENSOR (July 6, 2004)
K040183 — BISX (February 25, 2004)

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