PHZ

Abnormal Breath Sound Device

Product code
PHZ
Device name
Abnormal Breath Sound Device
Device class
Class 2
21 CFR
21 CFR 868.1900
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
7

FDA classification definition

The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-06-02.

NumberDecision dateApplicantDevice nameSummary
K2528442026-06-02Tyto Care , Ltd.Tyto Insights for Wheeze Detection (with PCCP)PDF
K2435672025-04-07Tyto Care , Ltd.Tyto Insights for Rhonchi DetectionPDF
K2405552024-07-02Tyto Care , Ltd.Tyto Insights for Crackles DetectionPDF
K2322372023-12-13Tyto Care , Ltd.Tyto Insights for Wheeze DetectionPDF

4 summaries are archived here for direct download.

Official FDA classification page: PHZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).