The following data is part of a premarket notification filed by Visia Imaging S.r.l with the FDA for Aladdin Hw3.0.
| Device ID | K160327 |
| 510k Number | K160327 |
| Device Name: | ALADDIN HW3.0 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | VISIA IMAGING S.R.L VIA MARTIRI DELLA LIBERTA 95/E San Giovanni Valdarno, IT 52027 |
| Contact | Silvia Fantechi |
| Correspondent | Marisa Testa THEMA S.R.L VIA SARAGAT 5 Imola, IT 40026 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-05 |
| Decision Date | 2016-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08034028770364 | K160327 | 000 |
| 08034028770470 | K160327 | 000 |