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FDA 510(k)

膠囊監控系統

K 號:K213335 · 2022-01-14

決定日期2022-01-14
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

Capsule Surveillance System is the device name listed in this FDA 510(k) record. The listed applicant is Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K213335. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Capsule Surveillance System?

Capsule Surveillance System is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. The 510(k) number is K213335.

When did Capsule Surveillance System receive FDA 510(k) clearance?

Capsule Surveillance System received FDA 510(k) clearance on 2022-01-14, under 510(k) number K213335.

Who is the listed applicant for Capsule Surveillance System?

The FDA 510(k) record lists Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capsule Surveillance System?

The FDA product code for Capsule Surveillance System is MWI.

相關臨床試驗

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相關器械(代碼:MWI)

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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