FDA 510(k)

NaviCam 小腸顱內鏡系統，配備 NaviCam SB 顱內鏡及 NaviCam 緊繫帶

K 號：K233229 · 2024-01-05

決定日期2024-01-05

產品代碼NEZ

諮詢委員會GU

決定相當於

器材摘要

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is the device name listed in this FDA 510(k) record. The listed applicant is Anx Robotica Corporation. It received FDA 510(k) clearance on 2024-01-05 under 510(k) number K233229. 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 NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is a medical device that received FDA 510(k) clearance on 2024-01-05. The listed applicant is Anx Robotica Corporation. The 510(k) number is K233229.

When did NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether receive FDA 510(k) clearance?

NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether received FDA 510(k) clearance on 2024-01-05, under 510(k) number K233229.

Who is the listed applicant for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

The FDA 510(k) record lists Anx Robotica Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether?

The FDA product code for NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether is NEZ.

其他以 Anx Robotica Corporation 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：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。

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官方來源

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