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FDA 510(k)

Neoscope 3D - 3D數位視覺內視鏡系統（硬式/柔軟式）

K 號：K152619 · 2016-04-29

申請人Prosurg, Inc.
決定日期2016-04-29
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is the device name listed in this FDA 510(k) record. The listed applicant is Prosurg, Inc.. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K152619. 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 Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Prosurg, Inc.. The 510(k) number is K152619.

When did Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) receive FDA 510(k) clearance?

Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) received FDA 510(k) clearance on 2016-04-29, under 510(k) number K152619.

Who is the listed applicant for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

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

What is the FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)?

The FDA product code for Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) is GCJ.

相關臨床試驗

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其他以 Prosurg, 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。

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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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