Device Classification Name |
tonometer, ac-powered
|
510(k) Number |
K963079 |
Device Name |
CANON TX-10 TONOMETER |
Applicant |
CANON U.S.A., INC. |
ONE CANON PLAZA |
LAKE SUCCESS,
NY
11042 -1198
|
|
Applicant Contact |
GLENN IMPAL |
Correspondent |
CANON U.S.A., INC. |
ONE CANON PLAZA |
LAKE SUCCESS,
NY
11042 -1198
|
|
Correspondent Contact |
GLENN IMPAL |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 08/07/1996 |
Decision Date | 03/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|