eKuore Pro 4T - REF EP0098
by Chip Ideas Electronics S.L.
510(k) K212013
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212013 | Date10 Nov 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1875
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The eKuore Pro 4T - REF EP0098 is an electronic stethoscope, a Class II medical device designed for auscultation of cardiac and vascular sounds. It amplifies and digitizes acoustic signals for clearer assessment of heart and lung conditions, supporting clinical evaluations in cardiovascular diagnostics. The device features four replaceable sensors, enabling versatile placement for optimal sound capture.
This device is supplied as a reusable, non-sterile instrument intended for use in clinical settings by healthcare professionals. It requires no special storage conditions but must be cleaned and disinfected between patients per standard infection control protocols. The eKuore Pro 4T holds FDA 510(k) clearance (K212013) under regulation 870.1875, classified under product code DQD for electronic stethoscopes. No MRI safety or sterility claims are stated in the regulatory data.
Other devices from Chip Ideas Electronics S.L.
Questions
AI-generated answers, 1 Oct 2026
What is the eKuore Pro 4T electronic stethoscope used for?
The eKuore Pro 4T (EP0098) is designed for auscultation of cardiac and vascular sounds. It amplifies and digitizes acoustic signals to improve the assessment of heart and lung conditions, aiding clinicians in cardiovascular diagnostics. The four replaceable sensors allow flexible placement for optimal sound capture during examinations.
How is the eKuore Pro 4T supplied and what are its sterility and reuse requirements?
The eKuore Pro 4T is supplied as a reusable, non-sterile device intended exclusively for clinical use by healthcare professionals. Since it is not sterile, it must be thoroughly cleaned and disinfected between patient use following standard infection control protocols to ensure safety and prevent cross-contamination.
Does the eKuore Pro 4T require special storage conditions?
No special storage conditions are required for the eKuore Pro 4T. It can be stored in a clean, dry environment, but adherence to cleaning and disinfection protocols between uses is mandatory to maintain its functionality and ensure patient safety.
What regulatory clearance does the eKuore Pro 4T hold?
The eKuore Pro 4T holds FDA 510(k) clearance under the classification of electronic stethoscopes (product code DQD) and regulation number 870.1875. The clearance was granted as substantially equivalent to predicate devices, with a decision date of November 10, 2021, following review by the FDA’s Cardiovascular Advisory Committee.
Can the eKuore Pro 4T be used in MRI environments?
The regulatory data for the eKuore Pro 4T does not specify MRI safety claims or compatibility. Clinicians should verify compatibility with their specific MRI system and protocols before use in an MRI environment to avoid potential interference or safety risks.