FDA 510(k)

Huvitz影像系統

K 號：K161829 · 2017-04-06

決定日期2017-04-06

產品代碼NFJ

諮詢委員會RA

決定相當於

器材摘要

Huvitz Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K161829. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Huvitz Imaging System?

Huvitz Imaging System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K161829.

When did Huvitz Imaging System receive FDA 510(k) clearance?

Huvitz Imaging System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K161829.

Who is the listed applicant for Huvitz Imaging System?

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

What is the FDA product code for Huvitz Imaging System?

The FDA product code for Huvitz Imaging System is NFJ.

其他以 Huvitz Co., Ltd. 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。

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相關器械（代碼：NFJ）

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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