Clearance Summary
TytoCare Lung Sounds Analyzer received FDA 510(k) clearance under submission number K221614, sponsored by Tyto Care , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2023-02-24.
- Submission: K221614
- Applicant / Sponsor: Tyto Care , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1900
- Decision date: 2023-02-24
Classification & Regulation
This clearance is catalogued under FDA product code PHZ and 21 CFR 868.1900, within the Anesthesiology review panel as a Class II device.