K252844
- 510(k) number
- K252844
- Device name
- Tyto Insights for Wheeze Detection (with PCCP)
- Applicant
- Tyto Care , Ltd. IL
- Product code
- PHZ — Abnormal Breath Sound Device
- Decision date
- 2026-06-02
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K252844.pdf
Official FDA record: K252844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.