FDA 510(k)

Optima XR646 HD

K 號：K173612 · 2017-12-11

決定日期2017-12-11

產品代碼KPR

諮詢委員會RA

決定相當於

器材摘要

Optima XR646 HD is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-11 under 510(k) number K173612. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optima XR646 HD?

Optima XR646 HD is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K173612.

When did Optima XR646 HD receive FDA 510(k) clearance?

Optima XR646 HD received FDA 510(k) clearance on 2017-12-11, under 510(k) number K173612.

Who is the listed applicant for Optima XR646 HD?

The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optima XR646 HD?

The FDA product code for Optima XR646 HD is KPR.

其他以 Ge Hualun Medical Systems Co. , Ltd. 為申請人之記錄

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相關器械（代碼：KPR）

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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