510(k) K974496

A-2000 EEG MONITOR WITH BIS by Aspect Medical Systems, Inc. — Product Code OLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 6, 1998
Date Received: November 28, 1997
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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K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
K041670 — BIS PEDIATRIC SENSOR (July 6, 2004)

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