The following data is part of a premarket notification filed by Centervue Spa with the FDA for Maia, Model 1.
| Device ID | K092187 |
| 510k Number | K092187 |
| Device Name: | MAIA, MODEL 1 |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | CENTERVUE SPA VIA TOMMASEO 77 Padova, IT 35131 |
| Contact | Giuliano Barbaro |
| Correspondent | Giuliano Barbaro CENTERVUE SPA VIA TOMMASEO 77 Padova, IT 35131 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-21 |
| Decision Date | 2010-05-27 |
| Summary: | summary |