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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Breath Sound Device
510(k) Number K260140
Device Name Aevice Wheeze Detection Module
Applicant
Aevice Health Pte. , Ltd.
3 Tai Seng Ave., Tai Seng Exchange Tower B #04-32
Singapore,  SG 536465
Applicant Contact Adrian Ang
Correspondent
Aevice Health Pte. , Ltd.
3 Tai Seng Ave., Tai Seng Exchange Tower B #04-32
Singapore,  SG 536465
Correspondent Contact Adrian Ang
Regulation Number868.1900
Classification Product Code
PHZ  
Date Received01/20/2026
Decision Date 09/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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