Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K943956 |
Device Name |
RETINA TOMOGRAPH AND FLOWMETER |
Applicant |
HEIDELBERG ENGINEERING |
OPTISCHE MEB SYSTEME GMBH |
IM NEUENHEIMER FELD 519 |
D06900 HEIDELBERG,GERMANY,
DE
|
|
Applicant Contact |
GERHARD ZINSER |
Correspondent |
HEIDELBERG ENGINEERING |
OPTISCHE MEB SYSTEME GMBH |
IM NEUENHEIMER FELD 519 |
D06900 HEIDELBERG,GERMANY,
DE
|
|
Correspondent Contact |
GERHARD ZINSER |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 08/15/1994 |
Decision Date | 11/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|