K203850 is an FDA 510(k) clearance for the CATS®-D Tonometer Prism. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Cats Tonometer, LLC (Tucson, US). The FDA issued a Cleared decision on June 14, 2021, 165 days after receiving the submission on December 31, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K203850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2020 |
| Decision Date | June 14, 2021 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKY - Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |