Device Classification Name |
device, fixation, ac-powered, ophthalmic
|
510(k) Number |
K801381 |
Device Name |
FITE FIXATION TOY FOR OCULAR EXAM |
Applicant |
FITE ENGINEERING CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
FITE ENGINEERING CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1290
|
Classification Product Code |
|
Date Received | 06/11/1980 |
Decision Date | 07/28/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|