Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K022037 |
Device Name |
XLTEK SLEEP SYSTEM |
Applicant |
EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE |
OAKVILLE, ONTARIO,
CA
L6H 5S1
|
|
Applicant Contact |
SONJA MARKEZ |
Correspondent |
EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE |
OAKVILLE, ONTARIO,
CA
L6H 5S1
|
|
Correspondent Contact |
SONJA MARKEZ |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|