The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Ic100.
| Device ID | K153694 |
| 510k Number | K153694 |
| Device Name: | Icare Ic100 |
| Classification | Tonometer, Manual |
| Applicant | Icare Finland Oy Ayritie 22 Vantaa, FI Fi-01510 |
| Contact | Matti Tulikoura |
| Correspondent | Matti Tulikoura Icare Finland Oy Ayritie 22 Vantaa, FI 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 | 2015-12-23 |
| Decision Date | 2016-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430033850473 | K153694 | 000 |