# P020001: Stan S31 Fetal Heart Monitor

- Pathway: PMA
- Applicant: Neoventa Medical AB
- Decided: Nov 1, 2005 after 1,399 days
- Product code: HEO (Analyzer, Data, Obstetric)
- Device class: 3
- Regulation: 21 CFR 884.2050
- 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. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P020001
Methodology: https://510kreport.com/methodology