FDA 510(k)

kleiner KG2 系統

K 號：K211474 · 2021-09-14

決定日期2021-09-14

產品代碼MAX

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決定相當於

器材摘要

Kleiner KG2 System is the device name listed in this FDA 510(k) record. The listed applicant is BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K211474. 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 Kleiner KG2 System?

Kleiner KG2 System is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K211474.

When did Kleiner KG2 System receive FDA 510(k) clearance?

Kleiner KG2 System received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211474.

Who is the listed applicant for Kleiner KG2 System?

The FDA 510(k) record lists BAAT Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kleiner KG2 System?

The FDA product code for Kleiner KG2 System is MAX.

其他以 BAAT Medical Products B.V. 為申請人之記錄

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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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