Device Classification Name |
Photostimulator, Ac-Powered
|
510(k) Number |
K810699 |
Device Name |
PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM |
Applicant |
VISIDYNE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
VISIDYNE CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1630
|
Classification Product Code |
|
Date Received | 03/16/1981 |
Decision Date | 06/09/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|