FDA 510(k)

TD-7301 肺功能儀 (TD-7301)

K 號：K241843 · 2024-11-20

決定日期2024-11-20

產品代碼BZG

諮詢委員會AN

決定相當於

器材摘要

TD-7301 Spirometer (TD-7301) is the device name listed in this FDA 510(k) record. The listed applicant is Gostar Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K241843. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TD-7301 Spirometer (TD-7301)?

TD-7301 Spirometer (TD-7301) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Gostar Co., Ltd.. The 510(k) number is K241843.

When did TD-7301 Spirometer (TD-7301) receive FDA 510(k) clearance?

TD-7301 Spirometer (TD-7301) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K241843.

Who is the listed applicant for TD-7301 Spirometer (TD-7301)?

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

What is the FDA product code for TD-7301 Spirometer (TD-7301)?

The FDA product code for TD-7301 Spirometer (TD-7301) is BZG.

其他以 Gostar Co., 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。

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相關器械（代碼：BZG）

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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