Device Classification Name |
device, nerve conduction velocity measurement
|
510(k) Number |
K935017 |
Device Name |
TD50 ELECTROMYOGRAPH |
Applicant |
MEDELEC INTL. CORP. |
MANOR WAY |
OLD WOKING, SURREY GU22 9JU |
ENGLAND,
GB
|
|
Applicant Contact |
J. B. HOLLOWAY |
Correspondent |
MEDELEC INTL. CORP. |
MANOR WAY |
OLD WOKING, SURREY GU22 9JU |
ENGLAND,
GB
|
|
Correspondent Contact |
J. B. HOLLOWAY |
Regulation Number | 882.1550
|
Classification Product Code |
|
Date Received | 10/19/1993 |
Decision Date | 07/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|