FDA 510(k)

蝴蝶孕期週數工具

K 號：K252148 · 2026-03-27

決定日期2026-03-27

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Butterfly Gestational Age Tool 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 2026-03-27 under 510(k) number K252148. 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 Gestational Age Tool?

Butterfly Gestational Age Tool is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K252148.

When did Butterfly Gestational Age Tool receive FDA 510(k) clearance?

Butterfly Gestational Age Tool received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252148.

Who is the listed applicant for Butterfly Gestational Age Tool?

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 Gestational Age Tool?

The FDA product code for Butterfly Gestational Age Tool 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）

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官方來源

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