FDA 510(k)

蝴蝶iQ3超聲系統

K 號：K232808 · 2024-01-04

決定日期2024-01-04

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Butterfly iQ3 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Butterfly Network, Inc.. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K232808. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Butterfly iQ3 Ultrasound System?

Butterfly iQ3 Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K232808.

When did Butterfly iQ3 Ultrasound System receive FDA 510(k) clearance?

Butterfly iQ3 Ultrasound System received FDA 510(k) clearance on 2024-01-04, under 510(k) number K232808.

Who is the listed applicant for Butterfly iQ3 Ultrasound System?

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

What is the FDA product code for Butterfly iQ3 Ultrasound System?

The FDA product code for Butterfly iQ3 Ultrasound System is IYN.

其他以 Butterfly Network, Inc. 為申請人之記錄

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相關器械（代碼：IYN）

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。

官方來源

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