XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40


Device Classification Name

standard polysomnograph with electroencephalograph

510(k) Number K991900
Device Name XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
Applicant
EXCEL TECH. LTD.
2892 portland dr.
oakville,ontario, 

CA

l6h 5w8

Applicant Contact mark t zajac
Correspondent
EXCEL TECH. LTD.
2892 portland dr.
oakville,ontario, 

CA

l6h 5w8

Correspodent Contact mark t zajac
Regulation Number 882.1400
Classification Product Code
OLV  
Date Received 06/04/1999
Decision Date 07/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No