FDA 510(k)

NOVA 微創系統

K 號：K182416 · 2019-06-11

決定日期2019-06-11

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

NOVA Minimally Invasive System is the device name listed in this FDA 510(k) record. The listed applicant is Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K182416. 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 NOVA Minimally Invasive System?

NOVA Minimally Invasive System is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Baui Biotech Co., Ltd.. The 510(k) number is K182416.

When did NOVA Minimally Invasive System receive FDA 510(k) clearance?

NOVA Minimally Invasive System received FDA 510(k) clearance on 2019-06-11, under 510(k) number K182416.

Who is the listed applicant for NOVA Minimally Invasive System?

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

What is the FDA product code for NOVA Minimally Invasive System?

The FDA product code for NOVA Minimally Invasive System is NKB.

其他以 Baui Biotech 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：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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