CORE 300 Digital Stethoscope— 510(k) K261694
Substantially EquivalentEko Health, Inc.
FDA 510(k) clearance K261694 for CORE 300 Digital Stethoscope, Substantially Equivalent on 2026-07-23. Applicant: Eko Health, Inc.. Device class: 2.
Summary
Eko Health's CORE 300 Digital Stethoscope is filed under DQD, electronic stethoscopes. The record doesn't give specs or list companion software.
Class II, 21 CFR 870.1875. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).
Eko Health filed from Emeryville, California. Review took 62 calendar days (May 22 to July 23, 2026).
Clearance details
- Applicant
- Eko Health, Inc.
- Product code
- Product code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emeryville, CA, US
Recent devices under product code DQD
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