FDA 510(k)

蝴蝶妊娠龄工具

K号: K252148 · 2026-03-27

决定日期2026-03-27

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Butterfly Network, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232808蝴蝶 iQ3 超声系统 K220068蝴蝶 iQ/iQ+ 超声系统 K202406蝴蝶 iQ 超声系统 K200980Auto 3D 膀胱容积工具 K163510波塞冬超声系统

相关器械（代码：IYN）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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