FDA Product Code PHZ: Abnormal Breath Sound Device
The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.
Leading manufacturers include Tyto Care , Ltd..
FDA 510(k) Cleared Abnormal Breath Sound Device Devices (Product Code PHZ)
About Product Code PHZ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PHZ since 2014, with 6 receiving FDA clearance (average review time: 228 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PHZ have taken an average of 133 days to reach a decision - down from 275 days historically, suggesting improved FDA processing for this classification.
PHZ devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →