96 CHANNEL EEG HEADBOX MODEL EMU96


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K021599
Device Name 96 CHANNEL EEG HEADBOX MODEL EMU96
Original Applicant
EXCEL TECH. LTD.
2568 bristol circle
oakville, ontario, 

CA

l6h 5s1

Original Contact john munford
Regulation Number 882.1400
Classification Product Code
GWQ  
Subsequent Product Code
DQA  
Date Received 05/15/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No