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510(k) K072286

BIS EEG VISTA MONITOR SYSTEM AND BISX by Aspect Medical Systems, Inc. — Product Code OLW

K072286 is an FDA 510(k) premarket notification submitted by Aspect Medical Systems, Inc. for the device "BIS EEG VISTA MONITOR SYSTEM AND BISX". The FDA issued a decision of Substantially Equivalent on November 20, 2007. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. Aspect Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2007
Date Received
August 16, 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.

Other clearances by Aspect Medical Systems, Inc.

  • K093183 — BIS QUATRO SENSOR (October 23, 2009)
  • K091854 — BIS CLICK SENSOR/CABLE (July 2, 2009)
  • 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)
  • K040183 — BISX (February 25, 2004)

Other clearances for product code OLW

  • K260880 — SedLine Sedation Monitor (July 10, 2026)
  • 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)
  • K071899 — BIS MODULE FOR ENVOY PATIENT MONITOR (October 22, 2007)

FDA data resources