Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K864641 |
Device Name |
VENTEX-IA |
Applicant |
VENTECH CORP. |
8627 FERNDALE ST. |
PHILADELPHIA,
PA
19115
|
|
Applicant Contact |
FREISHEIM, SR |
Correspondent |
VENTECH CORP. |
8627 FERNDALE ST. |
PHILADELPHIA,
PA
19115
|
|
Correspondent Contact |
FREISHEIM, SR |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 11/26/1986 |
Decision Date | 01/28/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|