DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES— 510(k) K000892

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K000892 for DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES, Substantially Equivalent on 2000-06-16. Applicant: Datex-Ohmeda, Inc..

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2000-03-20
Decision date: 2000-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tewksburt, MA, US

Download summary PDF View on FDA.gov ↗

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.