The following data is part of a premarket notification filed by Crystalvue Medical Corporation with the FDA for Tono Vue Non-contact Tonometer.
| Device ID | K180820 |
| 510k Number | K180820 |
| Device Name: | Tono Vue Non-Contact Tonometer |
| Classification | Tonometer, Ac-powered |
| Applicant | Crystalvue Medical Corporation No. 116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan, TW 33072 |
| Contact | Oliver Lin |
| Correspondent | Oliver Lin Crystalvue Medical Corporation No. 116, Ln.956, Zhongshan Rd., Taoyuan Dist., Taoyuan, TW 33072 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-29 |
| Decision Date | 2018-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851158007706 | K180820 | 000 |