Aevice Wheeze Detection Module
K-Number: K260140 · 2026-09-25
Device Summary
Frequently Asked Questions
What is the Aevice Wheeze Detection Module?
Aevice Wheeze Detection Module is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Aevice Health Pte. , Ltd.. The 510(k) number is K260140.
When did Aevice Wheeze Detection Module receive FDA 510(k) clearance?
Aevice Wheeze Detection Module received FDA 510(k) clearance on 2026-09-25, under 510(k) number K260140.
Who is the listed applicant for Aevice Wheeze Detection Module?
The FDA 510(k) record lists Aevice Health Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Aevice Wheeze Detection Module?
The FDA product code for Aevice Wheeze Detection Module is PHZ.
Other records listing Aevice Health Pte. , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PHZ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.