XLTEK SLEEP SYSTEM


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K022037
Device Name XLTEK SLEEP SYSTEM
Original Applicant
EXCEL TECH. LTD.
2568 bristol circle
oakville, ontario, 

CA

l6h 5s1

Original Contact sonja markez
Regulation Number 882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received 06/24/2002
Decision Date 09/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No