The following data is part of a premarket notification filed by Flaem Nuova S.p.a. with the FDA for Families Of Master Neb, Primo Neb, Sc03, Neb Aid, 4.2.neb, Q03, Fj03, And Walkie-neb.
| Device ID | K062014 |
| 510k Number | K062014 |
| Device Name: | FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB |
| 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 | 2006-07-17 |
| Decision Date | 2007-03-22 |
| Summary: | summary |