FDA 510(k)

Colibrí 系统

K号: K220546 · 2022-10-05

决定日期2022-10-05

产品代码LON

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决定实质等同

器械摘要

Colibrí System 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 2022-10-05 under 510(k) number K220546. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Colibrí System?

Colibrí System is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Copan Wasp Srl. The 510(k) number is K220546.

When did Colibrí System receive FDA 510(k) clearance?

Colibrí System received FDA 510(k) clearance on 2022-10-05, under 510(k) number K220546.

Who is the listed applicant for Colibrí System?

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 Colibrí System?

The FDA product code for Colibrí System is LON.

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。

K251511PhenoMATRIX K232756Colibrí K223245Colibrí K193138Colibri 系统

相关器械（代码：LON）

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。

K260282VITEK 2 AST-诱导克林霉素耐药性链球菌bioMerieux, Inc.K260281VITEK 2 AST-链球菌头孢呋辛（<=0.125 - >=8 µg/mL）BIOMERIEUX K251579VITEK 2 AST-革兰氏阴性头孢唑啉（=<1-=>32 µg/mL）bioMerieux, Inc.K251713BD Phoenix 自动微生物学系统 - GN 恩拉韦环素（0.125-2 µg/mL）Becton, Dickinson and Company K250447BD Phoenix® 自动微生物学系统 - GN 亚胺培南-雷巴匹坦（0.0625/4 - 16/4 µg/mL）Becton, Dickinson and Company K234012VITEK COMPACT PRObioMerieux, Inc.

官方来源

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