FDA 510(k)

AccurSound 電子聽診器 AS-101

K 號：K221805 · 2023-03-23

決定日期2023-03-23

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

AccurSound Electronic Stethoscope AS-101 is the device name listed in this FDA 510(k) record. The listed applicant is Heroic Faith International , Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K221805. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AccurSound Electronic Stethoscope AS-101?

AccurSound Electronic Stethoscope AS-101 is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Heroic Faith International , Ltd.. The 510(k) number is K221805.

When did AccurSound Electronic Stethoscope AS-101 receive FDA 510(k) clearance?

AccurSound Electronic Stethoscope AS-101 received FDA 510(k) clearance on 2023-03-23, under 510(k) number K221805.

Who is the listed applicant for AccurSound Electronic Stethoscope AS-101?

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

What is the FDA product code for AccurSound Electronic Stethoscope AS-101?

The FDA product code for AccurSound Electronic Stethoscope AS-101 is DQD.

其他以 Heroic Faith International , Ltd. 為申請人之記錄

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K242798Airmod K242971AccurSound Electronic Stethoscope (AS101)

相關器械（代碼：DQD）

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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