Device Classification Name |
Electrode, Cutaneous
|
510(k) Number |
K970426 |
Device Name |
VALUETRODE |
Applicant |
AXELGAARD MFG. CO., LTD. |
329 W. AVIATION RD. |
FALLBROOK,
CA
92028 -3227
|
|
Applicant Contact |
DAN JEFFERY |
Correspondent |
AXELGAARD MFG. CO., LTD. |
329 W. AVIATION RD. |
FALLBROOK,
CA
92028 -3227
|
|
Correspondent Contact |
DAN JEFFERY |
Regulation Number | 882.1320
|
Classification Product Code |
|
Date Received | 02/04/1997 |
Decision Date | 05/09/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|