The following data is part of a premarket notification filed by Tecnimed S.r.l. with the FDA for Visiofocus Mini, Visiofocus Smart.
| Device ID | K160680 |
| 510k Number | K160680 |
| Device Name: | VisioFocus Mini, VisioFocus Smart |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TECNIMED S.R.L. 12, P.LE COCCHI Vedano Olona, IT 21040 |
| Contact | Cinzia Bellifemine |
| Correspondent | Simona Daidone THEMA S.R.L VIA SARAGAT, 5 Imola, IT 40026 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-10 |
| Decision Date | 2017-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00182097000351 | K160680 | 000 |
| 00182097000245 | K160680 | 000 |
| 00182097000429 | K160680 | 000 |