K252089
- 510(k) number
- K252089
- Device name
- Tyto Stethoscope (G3)
- Applicant
- Tyto Care , Ltd. IL
- Product code
- DQD — Stethoscope, Electronic
- Decision date
- 2026-03-12
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252089.pdf
Official FDA record: K252089
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.