FDA.reportPublic FDA data

510(k) K000892

Device
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
Applicant
DATEX-OHMEDA, INC.
510(k) number
K000892
Product code
OLT  
Decision
Substantially Equivalent (SESE)
Decision date
2000-06-16
Date received
2000-03-20
Regulation
882.1400
Classification name
Non-normalizing Quantitative Electroencephalograph Software
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOEL KENT
Address
3 Highwood Dr. Tewksburt MA US 01876 01876

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases