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510(k) K050835

DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES by GE Healthcare — Product Code OLW

K050835 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 6, 2005. The device falls under product code OLW (Index-Generating Electroencephalograph Software), a Class II device regulated under 21 CFR 882.1400. GE Healthcare has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2005
Date Received
April 1, 2005
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 GE Healthcare

  • K253639 — View (January 8, 2026)
  • K242925 — MR Contour DL (April 1, 2025)
  • K241300 — ViewPoint 6 (July 2, 2024)
  • K232346 — Digital Expert Access with Remote Scanning (October 27, 2023)
  • K223212 — Precision DL (April 27, 2023)
  • K221680 — Xeleris V Processing and Review System (March 1, 2023)
  • K221932 — Omni Legend (September 2, 2022)
  • K213689 — Voluson P6, Voluson P8 (February 17, 2022)
  • K213642 — Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert (January 13, 2022)
  • K211488 — LOGIQ E10 (September 10, 2021)

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)
  • K072286 — BIS EEG VISTA MONITOR SYSTEM AND BISX (November 20, 2007)

FDA data resources