Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K971671 |
Device Name |
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) |
Applicant |
HEIDELBERG ENGINEERING |
TIERGARTENSTRASSE 17 |
HEIDELBERG,
DE
69121
|
|
Applicant Contact |
GERHARD ZINSER |
Correspondent |
HEIDELBERG ENGINEERING |
TIERGARTENSTRASSE 17 |
HEIDELBERG,
DE
69121
|
|
Correspondent Contact |
GERHARD ZINSER |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 05/07/1997 |
Decision Date | 07/29/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|