510(k) K002837

BIS ENGINE by Aspect Medical Systems, Inc. — Product Code OLW

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 19, 2000
Date Received: September 12, 2000
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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K062613 — BIS EEG MONITOR VIEW (June 18, 2007)
K070069 — ZIPPREP ELECTRODE (February 5, 2007)
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)
K050313 — BIS SRS (SEMI-RESUABLE SENSOR) (February 24, 2005)
K041670 — BIS PEDIATRIC SENSOR (July 6, 2004)

Other clearances for product code OLW

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K202621 — NeuroSENSE Monitoring System, Model NS-901 (August 5, 2021)
K172890 — SedLine Sedation Monitor (January 26, 2018)
K150298 — Entropy Module, E-ENTROPY-01 (November 12, 2015)
K083063 — BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (December 16, 2008)
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K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)
K071899 — BIS MODULE FOR ENVOY PATIENT MONITOR (October 22, 2007)