# K211779: ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.

- Pathway: 510(k) (Traditional)
- Applicant: Chip Ideas Electronics S.L.
- Decided: May 26, 2022 after 351 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K771653 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203007: eKuore Pro Series, Chip Ideas Electronics S.L. (2020) Summary page 4.

## Indications for use
The eKuore Stethoscope Touch is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. The eKuore Stethoscope Touch is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to a compatible software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

Source page: https://510kreport.com/device/K211779
Methodology: https://510kreport.com/methodology