K190382 is an FDA 510(k) clearance for the Intraocular Pressure Tonometer EASYTON. This device is classified as a Tonometer, Ac-powered (Class II - Special Controls, product code HKX).
Submitted by Company Elamed (Yelatma, RU). The FDA issued a Cleared decision on December 6, 2019, 290 days after receiving the submission on February 19, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K190382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | December 06, 2019 |
| Days to Decision | 290 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKX - Tonometer, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |