Home / Device Classification / PHZ

PHZ — Abnormal Breath Sound Device Class II

FDA Device Classification

Classification Details

Product Code
PHZ
Device Class
Class II
Regulation Number
868.1900
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243567tyto careTyto Insights for Rhonchi DetectionApril 7, 2025
K240555tyto careTyto Insights for Crackles DetectionJuly 2, 2024
K232237tyto careTyto Insights for Wheeze DetectionDecember 13, 2023
K221614tyto careTytoCare Lung Sounds AnalyzerFebruary 24, 2023
K202062respiri limitedwheezo WheezeRate DetectorMarch 11, 2021
K131285isoneaSONOSENTRYAugust 19, 2014