CapsoCam Plus (SV-3)
K 號：K183192 · 2019-04-19
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器材摘要
CapsoCam Plus (SV-3) is the device name listed in this FDA 510(k) record. The listed applicant is CapsoVision, Inc.. It received FDA 510(k) clearance on 2019-04-19 under 510(k) number K183192. 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)?
CapsoCam Plus (SV-3) is a medical device that received FDA 510(k) clearance on 2019-04-19. The listed applicant is CapsoVision, Inc.. The 510(k) number is K183192.
When did CapsoCam Plus (SV-3) receive FDA 510(k) clearance?
CapsoCam Plus (SV-3) received FDA 510(k) clearance on 2019-04-19, under 510(k) number K183192.
Who is the listed applicant for CapsoCam Plus (SV-3)?
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)?
The FDA product code for CapsoCam Plus (SV-3) is NEZ.
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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。
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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