FDA 510(k)

ROSA 準備架

K 號：K182672 · 2019-11-15

決定日期2019-11-15

產品代碼NJM

諮詢委員會DE

決定相當於

器材摘要

ROSA Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Gni Co., Ltd.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K182672. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ROSA Bracket?

ROSA Bracket is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Gni Co., Ltd.. The 510(k) number is K182672.

When did ROSA Bracket receive FDA 510(k) clearance?

ROSA Bracket received FDA 510(k) clearance on 2019-11-15, under 510(k) number K182672.

Who is the listed applicant for ROSA Bracket?

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

What is the FDA product code for ROSA Bracket?

The FDA product code for ROSA Bracket is NJM.

其他以 Gni Co., Ltd. 為申請人之記錄

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相關器械（代碼：NJM）

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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