PillCam COLON 2 胶囊內視鏡系統
K 號：K153466 · 2016-01-14
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器材摘要
PillCam COLON 2 Capsule Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2016-01-14 under 510(k) number K153466. The device is classified under product code PGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the PillCam COLON 2 Capsule Endoscopy System?
PillCam COLON 2 Capsule Endoscopy System is a medical device that received FDA 510(k) clearance on 2016-01-14. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K153466.
When did PillCam COLON 2 Capsule Endoscopy System receive FDA 510(k) clearance?
PillCam COLON 2 Capsule Endoscopy System received FDA 510(k) clearance on 2016-01-14, under 510(k) number K153466.
Who is the listed applicant for PillCam COLON 2 Capsule Endoscopy System?
The FDA 510(k) record lists Given Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PillCam COLON 2 Capsule Endoscopy System?
The FDA product code for PillCam COLON 2 Capsule Endoscopy System is PGD.
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其他以 Given Imaging , Ltd. 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。
官方來源
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