510(k) clearance
Aevice Wheeze Detection Module
- 510(k) number
- K260140
- Applicant
- Aevice Health Pte. , Ltd.
- Decision date
- Sep 25, 2026
- Date received
- Jan 20, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PHZ
- Device type
- Abnormal Breath Sound Device
- Device class
- Class II
- Regulation
- 21 CFR 868.1900
- Advisory committee
- Anesthesiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Singapore, SG