Device Classification Name |
device, biofeedback
|
510(k) Number |
K945286 |
Device Name |
THE BAGNOLI-2 EMG SYSTEM |
Applicant |
DELSYS, INC. |
30 YARMOUTH ROAD |
WELLESLEY,
MA
02181
|
|
Applicant Contact |
CARLO J DE LUCA |
Correspondent |
DELSYS, INC. |
30 YARMOUTH ROAD |
WELLESLEY,
MA
02181
|
|
Correspondent Contact |
CARLO J DE LUCA |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 10/31/1994 |
Decision Date | 09/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|