Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K942965 |
Device Name |
COMPUTER DYNO/GONIO/MYO GRAPHY |
Applicant |
INFOTRONIC MEDICAL ENGINEERING |
523 BENFIELD RD. |
SEVERNA PARK,
MD
21146
|
|
Applicant Contact |
KEES SMEEHUYZEN |
Correspondent |
INFOTRONIC MEDICAL ENGINEERING |
523 BENFIELD RD. |
SEVERNA PARK,
MD
21146
|
|
Correspondent Contact |
KEES SMEEHUYZEN |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/24/1994 |
Decision Date | 10/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|