510(k) K252089
K252089 is an FDA 510(k) premarket notification submitted by Tyto Care , Ltd. for the device "Tyto Stethoscope (G3)". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Tyto Care , Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 2026
- Date Received
- July 2, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Electronic
- Device Class
- Class II
- Regulation Number
- 870.1875
- Review Panel
- CV
- Submission Type