Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K772214 |
Device Name |
OPHTHALMOSCOPE, BINOCULAR, INDIRECT |
Applicant |
VARIAN ASSOC., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
VARIAN ASSOC., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 12/02/1977 |
Decision Date | 12/13/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|