The following data is part of a premarket notification filed by Company Elamed with the FDA for Intraocular Pressure Tonometer Easyton.
| Device ID | K190382 |
| 510k Number | K190382 |
| Device Name: | Intraocular Pressure Tonometer EASYTON |
| Classification | Tonometer, Ac-powered |
| Applicant | Company Elamed Yelatma Instrument-making Enterprise, JSC 391351, 25 Janina St., Yelatma, RU |
| Contact | Mikhail Kuzin |
| Correspondent | Mikhail Kuzin Company Elamed Yelatma Instrument-making Enterprise, JSC 391351, 25 Janina St., Yelatma, RU |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-12-06 |