FDA 510(k)

3d 金屬網籠

K 號：K180347 · 2019-10-28

決定日期2019-10-28

產品代碼MAX

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決定相當於

器材摘要

3d Cage is the device name listed in this FDA 510(k) record. The listed applicant is Fims Co., Ltd.. It received FDA 510(k) clearance on 2019-10-28 under 510(k) number K180347. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3d Cage?

3d Cage is a medical device that received FDA 510(k) clearance on 2019-10-28. The listed applicant is Fims Co., Ltd.. The 510(k) number is K180347.

When did 3d Cage receive FDA 510(k) clearance?

3d Cage received FDA 510(k) clearance on 2019-10-28, under 510(k) number K180347.

Who is the listed applicant for 3d Cage?

FDA 510(k) 記錄將 Fims Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for 3d Cage?

The FDA product code for 3d Cage is MAX.

其他以 Fims Co., Ltd. 為申請人之記錄

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K2530413D籠架頸椎

相關器械（代碼：MAX）

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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