Aevice Wheeze Detection Module— 510(k) K260140
Substantially EquivalentAevice Health Pte. , Ltd.
FDA 510(k) clearance K260140 for Aevice Wheeze Detection Module, Substantially Equivalent on 2026-09-25. Applicant: Aevice Health Pte. , Ltd.. Device class: 2.
Summary
The Aevice Wheeze Detection Module is filed under PHZ, abnormal breath sound devices. As the name says, it's meant to detect wheeze. The record doesn't describe the hardware or the patient population.
Class II, 21 CFR 868.1900. The Anesthesiology panel reviewed it as a Traditional 510(k).
Aevice Health Pte. Ltd. filed from Singapore. Review took 248 days (January 20 to September 25, 2026).
Clearance details
- Applicant
- Aevice Health Pte. , Ltd.
- Product code
- Product code PHZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.1900
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code PHZ
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