FDA 510(k)

L300 行動系統

K 號：K190285 · 2019-03-14

決定日期2019-03-14

產品代碼GZI

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

L300 Go System is the device name listed in this FDA 510(k) record. The listed applicant is Bioness, Inc.. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K190285. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the L300 Go System?

L300 Go System is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Bioness, Inc.. The 510(k) number is K190285.

When did L300 Go System receive FDA 510(k) clearance?

L300 Go System received FDA 510(k) clearance on 2019-03-14, under 510(k) number K190285.

Who is the listed applicant for L300 Go System?

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

What is the FDA product code for L300 Go System?

The FDA product code for L300 Go System is GZI.

其他以 Bioness, Inc. 為申請人之記錄

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相關器械（代碼：GZI）

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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官方來源

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