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FDA 510(k)

超声探头罩

K号: K241662 · 2024-08-30

决定日期2024-08-30
产品代码ITX
咨询委员会RA
决定实质等同

器械摘要

Ultrasound Transducer Cover is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife Sweden AB. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241662. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasound Transducer Cover?

Ultrasound Transducer Cover is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Vitrolife Sweden AB. The 510(k) number is K241662.

When did Ultrasound Transducer Cover receive FDA 510(k) clearance?

Ultrasound Transducer Cover received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241662.

Who is the listed applicant for Ultrasound Transducer Cover?

The FDA 510(k) record lists Vitrolife Sweden AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrasound Transducer Cover?

The FDA product code for Ultrasound Transducer Cover is ITX.

相关临床试验

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列明Vitrolife Sweden AB为申报人的其他记录

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相关器械(代码:ITX)

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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