Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K832996 |
Device Name |
SURGICAL IOP MONITOR |
Applicant |
MIAMI EYE TECHNOLOGY, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MIAMI EYE TECHNOLOGY, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1930 |
Classification Product Code |
|
Date Received | 09/02/1983 |
Decision Date | 11/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|