FDA 510(k)

Cellvizio 100系列系統搭配共聚焦迷你探針

K 號：K191144 · 2020-01-24

決定日期2020-01-24

產品代碼OWN

諮詢委員會GU

決定相當於

器材摘要

Cellvizio 100 Series System 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 2020-01-24 under 510(k) number K191144. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cellvizio 100 Series System with Confocal Miniprobes?

Cellvizio 100 Series System with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2020-01-24. The listed applicant is Mauna Kea Technologies. The 510(k) number is K191144.

When did Cellvizio 100 Series System with Confocal Miniprobes receive FDA 510(k) clearance?

Cellvizio 100 Series System with Confocal Miniprobes received FDA 510(k) clearance on 2020-01-24, under 510(k) number K191144.

Who is the listed applicant for Cellvizio 100 Series System 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 Cellvizio 100 Series System with Confocal Miniprobes?

The FDA product code for Cellvizio 100 Series System with Confocal Miniprobes is OWN.

其他以 Mauna Kea Technologies 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K220477Cellvizio 100系列系統搭配共聚焦Miniprobes K212322Cellvizio I.V.E. 系統搭配共聚焦迷你探針 K193416Cellvizio I.V.E. 配合共聚焦迷你探針 K183640Cellvizio 100 系列共聚焦雷射影像系統及其共聚焦迷你探針 K180270Cellvizio 100系列系統搭配共聚焦迷你探針 K172844Cellvizio 100系列系統搭配共聚焦迷你探針

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相關器械（代碼：OWN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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