EEG SPIKE AND EVENT DETECTOR MODULE


codes

Device Classification Name

automatic event detection software for full-montage electroencephalograph

510(k) Number K002332
Device Name EEG SPIKE AND EVENT DETECTOR MODULE
Original Applicant
EXCEL TECH. LTD.
2568 bristol circle
oakville, ontario, 

CA

l6h 5s1

Original Contact debbie davy
Regulation Number 882.1400
Classification Product Code
OMB  
Date Received 08/01/2000
Decision Date 10/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No