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FDA 510(k)

第三眼全景輔助內視鏡系統 - 負責

K 號：K160356 · 2016-05-17

申請人Avantis Medical Systems, Inc.
決定日期2016-05-17
產品代碼FDF
諮詢委員會GU
決定相當於

器材摘要

Third Eye Panoramic Auxiliary Endoscopy System - Resposable is the device name listed in this FDA 510(k) record. The listed applicant is Avantis Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K160356. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

Third Eye Panoramic Auxiliary Endoscopy System - Resposable is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Avantis Medical Systems, Inc.. The 510(k) number is K160356.

When did Third Eye Panoramic Auxiliary Endoscopy System - Resposable receive FDA 510(k) clearance?

Third Eye Panoramic Auxiliary Endoscopy System - Resposable received FDA 510(k) clearance on 2016-05-17, under 510(k) number K160356.

Who is the listed applicant for Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

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

What is the FDA product code for Third Eye Panoramic Auxiliary Endoscopy System - Resposable?

The FDA product code for Third Eye Panoramic Auxiliary Endoscopy System - Resposable is FDF.

相關臨床試驗

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相關器械（代碼：FDF）

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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