# K974079: Formula for Archimed

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: Jan 22, 1998 after 85 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- 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 K922703 (1993). 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)
- K922703: The Acta Formula, Biosound, Inc. (1993) Summary page 1.

## Indications for use
The Formula for ArchiMed line of electrocardiograph products is intended to be used by a physician to analyze cardiac performance

Source page: https://510kreport.com/device/K974079
Methodology: https://510kreport.com/methodology