FDA 510(k)

紧凑型II

K号: K251083 · 2025-09-12

决定日期2025-09-12

产品代码IPF

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决定实质等同

器械摘要

Compact II is the device name listed in this FDA 510(k) record. The listed applicant is Enraf-Nonius, B.V.. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K251083. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Compact II?

Compact II is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Enraf-Nonius, B.V.. The 510(k) number is K251083.

When did Compact II receive FDA 510(k) clearance?

Compact II received FDA 510(k) clearance on 2025-09-12, under 510(k) number K251083.

Who is the listed applicant for Compact II?

The FDA 510(k) record lists Enraf-Nonius, B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Compact II?

The FDA product code for Compact II is IPF.

列明Enraf-Nonius, B.V.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。

K243112Curapuls 670 K230472Sonopuls 190

官方来源

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