Device Classification Name |
tonometer, ac-powered
|
510(k) Number |
K023676 |
Device Name |
APPLANATION TONOMETER |
Applicant |
OPTILASA S.L. |
338 ARTURO SORIA ST. |
MADRID,
ES
28033
|
|
Applicant Contact |
JOSE M BOBES |
Correspondent |
OPTILASA S.L. |
338 ARTURO SORIA ST. |
MADRID,
ES
28033
|
|
Correspondent Contact |
JOSE M BOBES |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 11/01/2002 |
Decision Date | 04/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|