FDA 510(k)

3D 解剖模型

K 號：K230119 · 2023-05-02

決定日期2023-05-02

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

3D Anatomic Model is the device name listed in this FDA 510(k) record. The listed applicant is Ricoh USA, Inc.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230119. 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 3D Anatomic Model?

3D Anatomic Model is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Ricoh USA, Inc.. The 510(k) number is K230119.

When did 3D Anatomic Model receive FDA 510(k) clearance?

3D Anatomic Model received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230119.

Who is the listed applicant for 3D Anatomic Model?

The FDA 510(k) record lists Ricoh USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D Anatomic Model?

The FDA product code for 3D Anatomic Model is LLZ.

其他以 Ricoh USA, Inc. 為申請人之記錄

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K2202053D 解剖模型

相關器械（代碼：LLZ）

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官方來源

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