K232237
- 510(k) number
- K232237
- Device name
- Tyto Insights for Wheeze Detection
- Applicant
- Tyto Care , Ltd. IL
- Product code
- PHZ — Abnormal Breath Sound Device
- Decision date
- 2023-12-13
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K232237.pdf
Official FDA record: K232237
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.