FDA 510(k)

Copioumed 化療隔離袍

K 號：K230135 · 2023-10-04

決定日期2023-10-04

產品代碼FYC

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Copioumed Chemotherapy Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Copioumed International, Inc.. It received FDA 510(k) clearance on 2023-10-04 under 510(k) number K230135. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Copioumed Chemotherapy Isolation Gown?

Copioumed Chemotherapy Isolation Gown is a medical device that received FDA 510(k) clearance on 2023-10-04. The listed applicant is Copioumed International, Inc.. The 510(k) number is K230135.

When did Copioumed Chemotherapy Isolation Gown receive FDA 510(k) clearance?

Copioumed Chemotherapy Isolation Gown received FDA 510(k) clearance on 2023-10-04, under 510(k) number K230135.

Who is the listed applicant for Copioumed Chemotherapy Isolation Gown?

The FDA 510(k) record lists Copioumed International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Copioumed Chemotherapy Isolation Gown?

The FDA product code for Copioumed Chemotherapy Isolation Gown is FYC.

其他以 Copioumed International, Inc. 為申請人之記錄

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相關器械（代碼：FYC）

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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