FDA 510(k)

導航手術套件箱

K 號：K241492 · 2024-08-23

申請人JJGC Indústria e Comércio de Materiais Dentários S.A.

決定日期2024-08-23

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Guided Surgery Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K241492. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Guided Surgery Kit Cases?

Guided Surgery Kit Cases is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K241492.

When did Guided Surgery Kit Cases receive FDA 510(k) clearance?

Guided Surgery Kit Cases received FDA 510(k) clearance on 2024-08-23, under 510(k) number K241492.

Who is the listed applicant for Guided Surgery Kit Cases?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Surgery Kit Cases?

The FDA product code for Guided Surgery Kit Cases is KCT.