Device Classification Name |
device, biofeedback
|
510(k) Number |
K981934 |
Device Name |
THE BAGNOLI-4 EMG SYSTEM |
Applicant |
DELSYS, INC. |
PO BOX 15734 |
BOSTON,
MA
02215
|
|
Applicant Contact |
GIANLUCA DE LUCA |
Correspondent |
DELSYS, INC. |
PO BOX 15734 |
BOSTON,
MA
02215
|
|
Correspondent Contact |
GIANLUCA DE LUCA |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 06/02/1998 |
Decision Date | 08/31/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|