FDA 510(k)

PhenoMATRIX

K号: K251511 · 2026-01-22

决定日期2026-01-22

产品代码PPU

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决定实质等同

器械摘要

PhenoMATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Copan Wasp Srl. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K251511. The device is classified under product code PPU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PhenoMATRIX?

PhenoMATRIX is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Copan Wasp Srl. The 510(k) number is K251511.

When did PhenoMATRIX receive FDA 510(k) clearance?

PhenoMATRIX received FDA 510(k) clearance on 2026-01-22, under 510(k) number K251511.

Who is the listed applicant for PhenoMATRIX?

The FDA 510(k) record lists Copan Wasp Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PhenoMATRIX?

The FDA product code for PhenoMATRIX is PPU.

列明Copan Wasp Srl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。

K232756Colibrí K223245Colibrí K220546Colibrí 系统 K193138Colibri 系统

官方来源

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