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

Substantially Equivalent

GE Healthcare

Clearance details

Applicant: GE Healthcare
Product code: Code OLT
Advisory panel: Neurology
Date received: 2005-07-12
Decision date: 2005-08-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Needham, MA, US

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.