# K123030: Compressor Nebulizer Model MCN-S600XX

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Aidisy Machinery & Electronic Equipment C
- Decided: Dec 19, 2013 after 447 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Stronghealth Compressor Nebulizer MCN-S600XX is used to administer various aerosol treatments to adult in the homecare. its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. The intended environment for use of the product is in the patient's home on the order of a physician.

Source page: https://510kreport.com/device/K123030
Methodology: https://510kreport.com/methodology