DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.— 510(k) K051883

Name: FDA 510(k) clearance K051883
Creator: U.S. Food and Drug Administration
Published: 2005-08-05

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K051883 for DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES., Substantially Equivalent on 2005-08-05. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code OLT
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2005-07-12
Decision date: 2005-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OLT

view all

K254213 — Pascall Sensor Unit (PSU1)2026-08-19
K253767 — UB ERP System2026-06-30
K251881 — HippoMind (v1.0)2025-12-03
K251366 — EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)2025-10-09
K240593 — VEEGix EEG System2024-08-23

More clearances from GE Healthcare

view all

K253639 — View2026-01-08
K242925 — MR Contour DL2025-04-01
K232346 — Digital Expert Access with Remote Scanning2023-10-27
K223212 — Precision DL2023-04-27
K221680 — Xeleris V Processing and Review System2023-03-01

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.