Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K190316 |
Device Name |
Icare ic200 |
Applicant |
Icare Finland Oy |
Ayritie 22 |
Vantaa,
FI
01510
|
|
Applicant Contact |
Hannes Hyvonen |
Correspondent |
Icare Finland Oy |
Ayritie 22 |
Vantaa,
FI
01510
|
|
Correspondent Contact |
Hannes Hyvonen |
Regulation Number | 886.1930 |
Classification Product Code |
|
Date Received | 02/13/2019 |
Decision Date | 01/14/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|