510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260140Substantially Equivalent

Aevice Wheeze Detection Module

Aevice Health Pte. , Ltd., Singapore, SG / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(248 days to decision)
Product code
PHZ Abnormal Breath Sound Device
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Aevice Health Pte. , Ltd. 3 Tai Seng Ave., Tai Seng Exchange Tower B #04-32, Singapore, SG
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHZ

Trailing 12 months
2 clearances under product code PHZ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PHZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260