# K082878: Nevoni Classic, Model 6600-PO

- Pathway: 510(k) (Abbreviated)
- Applicant: Nsr Comercio E Representacoes Ltda
- Decided: Dec 30, 2008 after 92 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922623 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992643: Model Irc 1001 Aerosol Compressor, Invacare Corp. (1999) Summary page 2.
- K020932: Devilbiss Pulmo-Aide Compact Compressor, Sunrise Medical (2002) Summary page 2.
- K992285: Salter Aire Compressor, Salter Labs (2000) Summary page 2.
- K993492: Devilbiss Nebulizer Model 800, Sunrise Medical Hhg, Inc. (2000) Summary page 3.

## Indications for use
The Nevoni Classic 6600-PO nebulizer is an' ac powered portable compressor. This portable device uses a pneumatic piston that compresss air, forcing it to flow into the nebulizer cup. The force of the air flowing into tihe nebulizer cup disperses the medicine into fine mist particles for the inhalation~ treatment basel on a physician's prescription. This device is intended for single patient home therapy.

Source page: https://510kreport.com/device/K082878
Methodology: https://510kreport.com/methodology