The following data is part of a premarket notification filed by Flaem Nuova S.p.a. with the FDA for Flaem Nuova Rf6 Basic And Rf6 Plus Nebulizers.
| Device ID | K062484 |
| 510k Number | K062484 |
| Device Name: | FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | FLAEM NUOVA S.P.A. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell FLAEM NUOVA S.P.A. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-25 |
| Decision Date | 2007-06-08 |
| Summary: | summary |