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FDA 510(k)

CapsoCam Plus (SV-3) Capsule Endoscope System

K 號：K161773 · 2016-10-21

申請人CapsoVision, Inc.
決定日期2016-10-21
產品代碼NEZ
諮詢委員會GU
決定Substantially Equivalent

器材摘要

CapsoCam Plus (SV-3) Capsule Endoscope System is the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K161773. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CapsoCam Plus (SV-3) Capsule Endoscope System?

CapsoCam Plus (SV-3) Capsule Endoscope System is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is CapsoVision, Inc.. The 510(k) number is K161773.

When did CapsoCam Plus (SV-3) Capsule Endoscope System receive FDA 510(k) clearance?

CapsoCam Plus (SV-3) Capsule Endoscope System received FDA 510(k) clearance on 2016-10-21, under 510(k) number K161773.

Who is the listed applicant for CapsoCam Plus (SV-3) Capsule Endoscope System?

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

What is the FDA product code for CapsoCam Plus (SV-3) Capsule Endoscope System?

The FDA product code for CapsoCam Plus (SV-3) Capsule Endoscope System is NEZ.

相關臨床試驗

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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其他以 CapsoVision, 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。

K254230CapsoView (CVV); CapsoCloud (CLD)K252480CE Deliver (DLV)K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemK192662CapsoCam Plus (SV-3) Capsule Endoscopy SystemK183192CapsoCam Plus (SV-3)K151635CapsoCam (SV-1)

查看所有 7 項裝置 →

相關器械（代碼：NEZ）

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。

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

官方來源

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