Tyto Stethoscope (G3)— 510(k) K252089
Substantially EquivalentTyto Care , Ltd.
FDA 510(k) clearance K252089 for Tyto Stethoscope (G3), Substantially Equivalent on 2026-03-12. Applicant: Tyto Care , Ltd.. Device class: 2.
Summary
Tyto Care's Tyto Stethoscope (G3) is filed under DQD, electronic stethoscopes. The record doesn't describe the stethoscope beyond its name and that code name.
Class II, 21 CFR 870.1875. It was a Traditional 510(k), and Cardiovascular is both the classification panel and the review panel.
Tyto Care filed from Netanya, Israel. The decision came 253 calendar days after FDA received it (July 2, 2025 to March 12, 2026).
Clearance details
- Applicant
- Tyto Care , Ltd.
- 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
- Netanya, IL
Recent devices under product code DQD
view allMore clearances from Tyto Care , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.