FDA 510(k)

JiveX（型號編號 / 釋放版本：5.3）

K 號：K212321 · 2021-09-23

決定日期2021-09-23

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

JiveX (Model Number / Release: 5.3) is the device name listed in this FDA 510(k) record. The listed applicant is Visus Health IT GmbH. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212321. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JiveX (Model Number / Release: 5.3)?

JiveX (Model Number / Release: 5.3) is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Visus Health IT GmbH. The 510(k) number is K212321.

When did JiveX (Model Number / Release: 5.3) receive FDA 510(k) clearance?

JiveX (Model Number / Release: 5.3) received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212321.

Who is the listed applicant for JiveX (Model Number / Release: 5.3)?

The FDA 510(k) record lists Visus Health IT GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JiveX (Model Number / Release: 5.3)?

The FDA product code for JiveX (Model Number / Release: 5.3) is LLZ.

其他以 Visus Health IT GmbH 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。

K231041JiveX（型號編號 / 釋放版本：5.4）K200703JiveX K181964JiveX

相關器械（代碼：LLZ）

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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