510(k) K031694

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 29, 2003
Date Received: June 2, 2003
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.

Other clearances by Aspect Medical Systems, Inc.

K093183 — BIS QUATRO SENSOR (October 23, 2009)
K091854 — BIS CLICK SENSOR/CABLE (July 2, 2009)
K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)
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

K230693 — BIS Advance Monitoring System (February 26, 2024)
K213273 — Brain Anesthesia Response Monitor (Bar Monitor) (September 1, 2023)
K203113 — Masimo SedLine Sedation Monitor and Accessories (February 25, 2022)
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)
K061907 — MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (March 27, 2008)
K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)
K071899 — BIS MODULE FOR ENVOY PATIENT MONITOR (October 22, 2007)