Device Classification Name |
Camera, Ophthalmic, Ac-Powered
|
510(k) Number |
K953973 |
Device Name |
ANGIOVISION 1000 |
Applicant |
MEDIVISION MEDICAL IMAGING, LTD. |
THE MANOR HOUSE |
TWO HAYDEN ROWE |
HOPKINTON,
MA
01748
|
|
Applicant Contact |
RICHARD A DOMAINGUE |
Correspondent |
MEDIVISION MEDICAL IMAGING, LTD. |
THE MANOR HOUSE |
TWO HAYDEN ROWE |
HOPKINTON,
MA
01748
|
|
Correspondent Contact |
RICHARD A DOMAINGUE |
Regulation Number | 886.1120
|
Classification Product Code |
|
Date Received | 08/23/1995 |
Decision Date | 11/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|