FDA 510(k)

肺功能測試儀，型號：A9

K 號：K231561 · 2024-02-21

申請人Guangzhou Homesun Medical Technology Co., Ltd.

決定日期2024-02-21

產品代碼BTY

諮詢委員會AN

決定相當於

器材摘要

Pulmonary Function Tester, Model: A9 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Homesun Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-21 under 510(k) number K231561. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulmonary Function Tester, Model: A9?

Pulmonary Function Tester, Model: A9 is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Guangzhou Homesun Medical Technology Co., Ltd.. The 510(k) number is K231561.

When did Pulmonary Function Tester, Model: A9 receive FDA 510(k) clearance?

Pulmonary Function Tester, Model: A9 received FDA 510(k) clearance on 2024-02-21, under 510(k) number K231561.

Who is the listed applicant for Pulmonary Function Tester, Model: A9?

The FDA 510(k) record lists Guangzhou Homesun Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulmonary Function Tester, Model: A9?

The FDA product code for Pulmonary Function Tester, Model: A9 is BTY.

其他以 Guangzhou Homesun Medical Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：BTY）

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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