FDA 510(k)

預先

K 號：K170861 · 2017-08-04

申請人Shandong Weigao Orthopaedic Device Co., Ltd.

決定日期2017-08-04

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Premier is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Weigao Orthopaedic Device Co., Ltd.. It received FDA 510(k) clearance on 2017-08-04 under 510(k) number K170861. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Premier?

Premier is a medical device that received FDA 510(k) clearance on 2017-08-04. The listed applicant is Shandong Weigao Orthopaedic Device Co., Ltd.. The 510(k) number is K170861.

When did Premier receive FDA 510(k) clearance?

Premier received FDA 510(k) clearance on 2017-08-04, under 510(k) number K170861.

Who is the listed applicant for Premier?

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

What is the FDA product code for Premier?

The FDA product code for Premier is NKB.

其他以 Shandong Weigao Orthopaedic Device Co., Ltd. 為申請人之記錄

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K160320預先

相關器械（代碼：NKB）

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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