The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Home Tonometer.
| Device ID | K200966 |
| 510k Number | K200966 |
| Device Name: | Icare HOME Tonometer |
| Classification | Tonometer, Manual |
| Applicant | Icare Finland Oy Ayritie 22 Vantaa, FI 01510 |
| Contact | Hannes Hyvonen |
| Correspondent | Hannes Hyvonen Icare Finland Oy Ayritie 22 Vantaa, FI 01510 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-10 |
| Decision Date | 2020-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430033851074 | K200966 | 000 |
| 06430033850985 | K200966 | 000 |