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PHZClass II

Abnormal Breath Sound Device

21 CFR 868.1900 / Anesthesiology
FDA source (opens on fda.gov)

PHZ is the FDA product code for Abnormal Breath Sound Device, a class II device type, regulated under 21 CFR 868.1900. FDA's definition for this code reads: "The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PHZ
Device name
Abnormal Breath Sound Device
FDA definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
8
Ingested recalls
0

Clearances, product code PHZ

By decision year
8 clearances under product code PHZ with a decision year between 2014 and 2026, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PHZ by decision year
YearClearances
20141
20211
20232
20241
20251
20262

Applicants with the most clearances

Product code PHZ
Applicants holding the most 510(k) clearances under product code PHZ
ApplicantClearances
Tyto Care Inc.5
Aevice Health Pte. , Ltd.1
Isonea, Ltd.1
Respiri Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code