Device Classification Name |
tonometer, ac-powered
|
510(k) Number |
K060780 |
Device Name |
TONOMETER DIATON |
Applicant |
RYAZAN STATE INSTRUMENTS |
151 EAST WALNUT STREET |
LONG BEACH,
NY
11561
|
|
Applicant Contact |
BORIS KUN |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 03/22/2006 |
Decision Date | 04/06/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|