FDA 510(k)

Aevice Wheeze Detection Module

K 號：K260140 · 2026-09-25

決定日期2026-09-25

產品代碼PHZ

諮詢委員會AN

決定Substantially Equivalent

器材摘要

Aevice Wheeze Detection Module is the device name listed in this FDA 510(k) record. The listed applicant is Aevice Health Pte. , Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K260140. The device is classified under product code PHZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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.

其他以 Aevice Health Pte. , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243603AeviceMD K223382AeviceMD

相關器械（代碼：PHZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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