Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K163343 |
Device Name |
Icare HOME tonometer |
Applicant |
Icare Finland Oy |
Ayritie 22 |
Vantaa,
FI
01510
|
|
Applicant Contact |
Matti Tulikoura |
Correspondent |
DuVal & Associates, P.A. |
1820 Medical Arts Building, 825 Nicollet Mall |
Minneapolis,
MN
55402
|
|
Correspondent Contact |
Mark DuVal |
Regulation Number | 886.1930
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/29/2016 |
Decision Date | 03/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|