FDA 510(k)

PillCam SB 3 胶囊內視鏡系統，PillCam 軟體 9.0E

K 號：K230991 · 2023-06-30

決定日期2023-06-30

產品代碼NEZ

諮詢委員會GU

決定相當於

器材摘要

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging Ltd. (Medtronic). It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230991. 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 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Given Imaging Ltd. (Medtronic). The 510(k) number is K230991.

When did PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E receive FDA 510(k) clearance?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230991.

Who is the listed applicant for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA 510(k) record lists Given Imaging Ltd. (Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is NEZ.

其他以 Given Imaging Ltd. (Medtronic) 為申請人之記錄

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K211684PillCam SB 3 胶囊內視鏡系統，PillCam 軟體 9.0E

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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