Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K973355 |
Device Name |
ADVANTAGE 3000 |
Applicant |
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX |
100 COLLIP CIRCLE, #100 |
LONDON,
CA
N6G 4X8
|
|
Applicant Contact |
ROBERT SNOW |
Correspondent |
ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX |
100 COLLIP CIRCLE, #100 |
LONDON,
CA
N6G 4X8
|
|
Correspondent Contact |
ROBERT SNOW |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 09/08/1997 |
Decision Date | 12/05/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|