Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K081756 |
Device Name |
OCULAR RESPONSE ANALYZER |
Applicant |
REICHERT INC. |
3362 WALDEN AVE. |
DEPEW,
NY
14043
|
|
Applicant Contact |
SANDRA BROWN |
Correspondent |
REICHERT INC. |
3362 WALDEN AVE. |
DEPEW,
NY
14043
|
|
Correspondent Contact |
SANDRA BROWN |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 06/20/2008 |
Decision Date | 08/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|