K261694
- 510(k) number
- K261694
- Device name
- CORE 300 Digital Stethoscope
- Applicant
- Eko Health, Inc. CA · US
- Product code
- DQD — Stethoscope, Electronic
- Decision date
- 2026-07-23
- Date received
- 2026-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K261694.pdf
Official FDA record: K261694
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.