# K970844: Atomisor

- Pathway: 510(k) (Traditional)
- Applicant: Medical Consulting Service, Inc.
- Decided: Nov 13, 1997 after 251 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. The FDA summary names its predicate without a number.
- (no number) PRONEB (Pariboy): named in the summary without a submission number

## Indications for use
The ATOMISOR AL + NLS NEBULIZER is an aerosol generator for the delivery of aerosol to the airways. Because they have been designed to be operated together, the ATOMISOR NLS nebulizer and the ATOMISOR AL compressor should never be used separately. Caution : Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K970844
Methodology: https://510kreport.com/methodology