FDA 510(k)

CystoFlex UHD R-C，CelioFlex UHD 5-C，Cellvizio 100系列（800）带共聚焦微探针

K号: K160416 · 2016-05-20

决定日期2016-05-20

产品代码OWN

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决定实质等同

器械摘要

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with 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 2016-05-20 under 510(k) number K160416. 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 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Mauna Kea Technologies. The 510(k) number is K160416.

When did CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes receive FDA 510(k) clearance?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes received FDA 510(k) clearance on 2016-05-20, under 510(k) number K160416.

Who is the listed applicant for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with 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 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

The FDA product code for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with 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 K183640Cellvizio 100系列共聚焦激光成像系统和它们的共聚焦微探头 K180270Cellvizio 100系列系统配备共聚焦微探头

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官方来源

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