Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K951132 |
Device Name |
ANGIOSCAN (AS STAND ALONE INSTRUMENT) |
Applicant |
CARLZEISS MEDITEC INC. |
9550 WAPLES STREET,STE 105 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
ANDREAS W DREHER |
Correspondent |
CARLZEISS MEDITEC INC. |
9550 WAPLES STREET,STE 105 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
ANDREAS W DREHER |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 03/13/1995 |
Decision Date | 06/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|