Device Classification Name |
tonometer, ac-powered
|
510(k) Number |
K871335 |
Device Name |
TOPCON COMPUTERIZED TONOMETER CT-10 |
Applicant |
TOPCON INSTRUMENT CORPORATION OF AMERICA |
65 WEST CENTURY RD. |
PARAMUS,
NJ
07652
|
|
Applicant Contact |
GORDON W SITEMAN |
Correspondent |
TOPCON INSTRUMENT CORPORATION OF AMERICA |
65 WEST CENTURY RD. |
PARAMUS,
NJ
07652
|
|
Correspondent Contact |
GORDON W SITEMAN |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 04/03/1987 |
Decision Date | 05/18/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|