# Flaem Nuova S.P.A.

- Location (FDA's records): North Reading, MA
- FDA decisions: 2 (2007–2007): 2 510(k) clearances
- Product codes: CAF (2)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Salter Labs: 2 (https://510kreport.com/company/salter-labs)
- Respironics Healthscan, Inc.: 1 (https://510kreport.com/company/respironics-healthscan)
- Healthdyne, Inc.: 1 (https://510kreport.com/company/healthdyne)
- Invacare Corp.: 1 (https://510kreport.com/company/invacare)
- Pari Holding Co.: 1 (https://510kreport.com/company/pari-holding)
- Inspired Medical Products, Ltd.: 1 (https://510kreport.com/company/inspired-medical-products)

## Recent decisions
- K062484: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers (Jun 8, 2007)
- K062014: Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb (Mar 22, 2007)

Source page: https://510kreport.com/company/flaem-nuova