DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES


Device Classification Name

non-normalizing quantitative electroencephalograph software

510(k) Number K000892
Device Name DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
Original Applicant
DATEX-OHMEDA, INC.
3 highwood dr.
tewksbury, 
MA 
01876

Original Contact joel kent
Regulation Number 882.1400
Classification Product Code
OLT  
Subsequent Product Codes
OMC   ORT  
Date Received 03/20/2000
Decision Date 06/16/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No