FDA 510(k)

Cellvizio 100系列共聚焦激光成像系统和它们的共聚焦微探头

K号: K183640 · 2019-02-22

决定日期2019-02-22

产品代码OWN

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决定实质等同

器械摘要

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is the device name listed in this FDA 510(k) record. The listed applicant is Mauna Kea Technologies. It received FDA 510(k) clearance on 2019-02-22 under 510(k) number K183640. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2019-02-22. The listed applicant is Mauna Kea Technologies. The 510(k) number is K183640.

When did Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes receive FDA 510(k) clearance?

Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes received FDA 510(k) clearance on 2019-02-22, under 510(k) number K183640.

Who is the listed applicant for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

The FDA 510(k) record lists Mauna Kea Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes?

The FDA product code for Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes is OWN.

列明Mauna Kea Technologies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。

K220477Cellvizio 100系列系统配备共聚焦微探头 K212322Cellvizio I.V.E.系统配备共聚焦微探头 K193416Cellvizio I.V.E.配备共聚焦微探头 K191144Cellvizio 100系列系统，配备共聚焦微探头 K180270Cellvizio 100系列系统配备共聚焦微探头 K172844Cellvizio 100系列系统，配备共聚焦微探头

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