FDA 510(k)

CIV-透明蓋

K 號：K211270 · 2021-09-13

決定日期2021-09-13

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

CIV-Clear cover is the device name listed in this FDA 510(k) record. The listed applicant is CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2021-09-13 under 510(k) number K211270. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CIV-Clear cover?

CIV-Clear cover is a medical device that received FDA 510(k) clearance on 2021-09-13. The listed applicant is CIVCO Medical Instruments Co., Inc.. The 510(k) number is K211270.

When did CIV-Clear cover receive FDA 510(k) clearance?

CIV-Clear cover received FDA 510(k) clearance on 2021-09-13, under 510(k) number K211270.

Who is the listed applicant for CIV-Clear cover?

FDA 510(k) 記錄將 CIVCO Medical Instruments Co., Inc. 列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for CIV-Clear cover?

The FDA product code for CIV-Clear cover is ITX.

其他以 CIVCO Medical Instruments Co., 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。

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相關器械（代碼：ITX）

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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