K243567
- 510(k) number
- K243567
- Device name
- Tyto Insights for Rhonchi Detection
- Applicant
- Tyto Care , Ltd. IL
- Product code
- PHZ — Abnormal Breath Sound Device
- Decision date
- 2025-04-07
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243567.pdf
Official FDA record: K243567
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.