K240555
- 510(k) number
- K240555
- Device name
- Tyto Insights for Crackles Detection
- Applicant
- Tyto Care , Ltd. IL
- Product code
- PHZ — Abnormal Breath Sound Device
- Decision date
- 2024-07-02
- Date received
- 2024-02-28
- 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: K240555.pdf
Official FDA record: K240555
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.