The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Ic200.
| Device ID | K220852 |
| 510k Number | K220852 |
| Device Name: | ICare IC200 |
| Classification | Tonometer, Manual |
| Applicant | Icare Finland Oy Ayritie 22 Vantaa, FI 01510 |
| Contact | Hannes Hyvönen |
| Correspondent | Hannes Hyvönen Icare Finland Oy Ayritie 22 Vantaa, FI 01510 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-23 |
| Decision Date | 2022-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430033851463 | K220852 | 000 |