# K912335: Artema Aqua+ N

- Pathway: 510(k) (Traditional)
- Applicant: Artema Medical AB
- Decided: Jul 26, 1991 after 63 days
- Product code: BYD (Condenser, Heat And Moisture (Artificial Nose))
- Device class: 1
- Regulation: 21 CFR 868.5375
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K912335
Methodology: https://510kreport.com/methodology