Device Classification Name |
Ophthalmoscope, Ac-Powered
|
510(k) Number |
K951728 |
Device Name |
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE |
Applicant |
MIRA, INC. |
87 RUMFORD AVE. |
WALTHAM,
MA
02453 -3846
|
|
Applicant Contact |
ROGER R O'BRIEN |
Correspondent |
MIRA, INC. |
87 RUMFORD AVE. |
WALTHAM,
MA
02453 -3846
|
|
Correspondent Contact |
ROGER R O'BRIEN |
Regulation Number | 886.1570
|
Classification Product Code |
|
Date Received | 04/13/1995 |
Decision Date | 03/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|