Device Classification Name |
ophthalmoscope, ac-powered
|
510(k) Number |
K871268 |
Device Name |
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE |
Applicant |
G. RODENSTOCK INSTRUMENTE GMBH |
DRACHENSEESTRABE 10-12 |
POSTFACH 701560, D-8000 |
MUNCHEN 70, WEST GERMANY,
DE
|
|
Applicant Contact |
KLINGBEIL |
Correspondent |
G. RODENSTOCK INSTRUMENTE GMBH |
DRACHENSEESTRABE 10-12 |
POSTFACH 701560, D-8000 |
MUNCHEN 70, WEST GERMANY,
DE
|
|
Correspondent Contact |
KLINGBEIL |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 03/31/1987 |
Decision Date | 06/10/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|