The following data is part of a premarket notification filed by Icare Finland Oy with the FDA for Icare Home Tonometer.
| Device ID | K163343 |
| 510k Number | K163343 |
| Device Name: | Icare HOME Tonometer |
| Classification | Tonometer, Manual |
| Applicant | Icare Finland Oy Ayritie 22 Vantaa, FI 01510 |
| Contact | Matti Tulikoura |
| Correspondent | Mark Duval DuVal & Associates, P.A. 1820 Medical Arts Building, 825 Nicollet Mall Minneapolis, MN 55402 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-29 |
| Decision Date | 2017-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430033850626 | K163343 | 000 |
| 06430033850237 | K163343 | 000 |
| 16430033850623 | K163343 | 000 |
| 06430033850947 | K163343 | 000 |