DeviceClearance

Product code PHZ— Anesthesiology

SONOSENTRY

Classification name
Abnormal Breath Sound Device
Device class
Class 2
Regulation
21 CFR 868.1900
Advisory panel
Anesthesiology
Total cleared
7
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PHZ under 21 CFR 868.1900, via openFDA

Market context for product code PHZ

FDA has cleared 7 devices under product code PHZ between 2014 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PHZ

Recent clearances under product code PHZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.