# K973922: Archimed 4210 and 4220

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: May 12, 1998 after 209 days
- Product code: LOS
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902368 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902368: Personal 120/210 Basic Electrocardiograph, Esaote Biomedica Spa (1990) Summary page 1.

## Indications for use
The ArchiMed line of electrocardiograph products is used to record standard electrocardiographs at patient resting or exercising. Resting ECGs are automatically measured and interpreted by the optionally available interpretive software.

Source page: https://510kreport.com/device/K973922
Methodology: https://510kreport.com/methodology