Home / 510(k) Clearances / K213273

510(k) K213273

Brain Anesthesia Response Monitor (Bar Monitor) by Cortical Dynamics , Ltd. — Product Code OLW

K213273 is an FDA 510(k) premarket notification submitted by Cortical Dynamics , Ltd. for the device "Brain Anesthesia Response Monitor (Bar Monitor)". The FDA issued a decision of Substantially Equivalent on September 1, 2023. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2023
Date Received
September 30, 2021
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 for product code OLW

  • K260880 — SedLine Sedation Monitor (July 10, 2026)
  • K230693 — BIS™ Advance Monitoring System (February 26, 2024)
  • 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)

FDA data resources