Tyto Insights for Wheeze Detection (with PCCP)
Device Facts
| Record ID | K252844 |
|---|---|
| Device Name | Tyto Insights for Wheeze Detection (with PCCP) |
| Applicant | Tyto Care , Ltd. |
| Product Code | PHZ · Anesthesiology |
| Decision Date | Jun 2, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.1900 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.
