Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K961171 |
Device Name |
HUMPHREY OCT SCANNER |
Applicant |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Applicant Contact |
KENNETH M NICOLL |
Correspondent |
CARL ZEISS, INC. |
ONE ZEISS DR. |
THORNWOOD,
NY
10594
|
|
Correspondent Contact |
KENNETH M NICOLL |
Regulation Number | 886.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/25/1996 |
Decision Date | 06/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|