FDA 510(k)

JiveX（モデル番号 / リリース：5.3）

K番号: K212321 · 2021-09-23

決定日2021-09-23

製品コードLLZ

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてVisus Health IT GmbHを記載するその他の記録

K231041JiveX（モデル番号 / リリース：5.4）K200703JiveX K181964JiveX

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