FDA 510(k)

Auto 3D 膀胱容积工具

K号: K200980 · 2020-06-11

决定日期2020-06-11

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Auto 3D Bladder Volume 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 2020-06-11 under 510(k) number K200980. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Auto 3D Bladder Volume Tool?

Auto 3D Bladder Volume Tool is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K200980.

When did Auto 3D Bladder Volume Tool receive FDA 510(k) clearance?

Auto 3D Bladder Volume Tool received FDA 510(k) clearance on 2020-06-11, under 510(k) number K200980.

Who is the listed applicant for Auto 3D Bladder Volume 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 Auto 3D Bladder Volume Tool?

The FDA product code for Auto 3D Bladder Volume Tool is IYO.

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。

K252148蝴蝶妊娠龄工具 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 K163510波塞冬超声系统

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。