FDA 510(k)

內視鏡鏡頭保護裝置

K 號：K160172 · 2016-04-21

決定日期2016-04-21

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

Laparoscope Lens Shield Device is the device name listed in this FDA 510(k) record. The listed applicant is Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K160172. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Laparoscope Lens Shield Device?

Laparoscope Lens Shield Device is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Medeon Biodesign, Inc.. The 510(k) number is K160172.

When did Laparoscope Lens Shield Device receive FDA 510(k) clearance?

Laparoscope Lens Shield Device received FDA 510(k) clearance on 2016-04-21, under 510(k) number K160172.

Who is the listed applicant for Laparoscope Lens Shield Device?

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

What is the FDA product code for Laparoscope Lens Shield Device?

The FDA product code for Laparoscope Lens Shield Device is GCJ.

其他以 Medeon Biodesign, Inc. 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。

K200902ClickClean K193652AbClose - 積極關閉設備 K192891內視鏡鏡頭保護裝置（LENS）K170103內視鏡鏡頭保護裝置（LENS）K160117AbClose - 積極關閉設備

相關器械（代碼：GCJ）

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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