The following data is part of a premarket notification filed by Tiolat Oy with the FDA for Icare Tonometer Ta01i.
| Device ID | K063873 |
| 510k Number | K063873 |
| Device Name: | ICARE TONOMETER TA01I |
| Classification | Tonometer, Manual |
| Applicant | TIOLAT OY 8404 SUNSTATE STREET Tampa, FL 33634 |
| Contact | Nelson Tobin |
| Correspondent | Nelson Tobin TIOLAT OY 8404 SUNSTATE STREET Tampa, FL 33634 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-29 |
| Decision Date | 2007-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06430033850565 | K063873 | 000 |
| 06430033850060 | K063873 | 000 |