FDA 510(k)

聽診器 v1

K 號：K222871 · 2023-03-29

決定日期2023-03-29

產品代碼DQD

諮詢委員會履歷

決定相當於

器材摘要

Stethophone v1 is the device name listed in this FDA 510(k) record. The listed applicant is Sparrow Acoustics, Inc.. It received FDA 510(k) clearance on 2023-03-29 under 510(k) number K222871. 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 Stethophone v1?

Stethophone v1 is a medical device that received FDA 510(k) clearance on 2023-03-29. The listed applicant is Sparrow Acoustics, Inc.. The 510(k) number is K222871.

When did Stethophone v1 receive FDA 510(k) clearance?

Stethophone v1 received FDA 510(k) clearance on 2023-03-29, under 510(k) number K222871.

Who is the listed applicant for Stethophone v1?

The FDA 510(k) record lists Sparrow Acoustics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stethophone v1?

The FDA product code for Stethophone v1 is DQD.

其他以 Sparrow Acoustics, Inc. 為申請人之記錄

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