FDA 510(k)

卡迪那爾健康™多層塗層開背保護袍

K 號：K182830 · 2019-04-26

決定日期2019-04-26

產品代碼QPC

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

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K182830. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K182830.

When did Cardinal HealthTM Poly-Coated Open-Back Protective Gown receive FDA 510(k) clearance?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182830.

Who is the listed applicant for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown is QPC.

其他以 Cardinal Health200, LLC 為申請人之記錄

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相關器械（代碼：QPC）

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。

K262007PRIMED AAMI等級3開背袍PRIMED Medical Products, Inc.K261115VR®個人防護等級4袍子（VR袍子）PolyConversions, Inc.K252940VR®個人防護等級3袍子（VR袍子）PolyConversions, Inc.K242689AAMI 等級 4 保護；大褲Azac Group K233526美林開放式3級保護衣Medline Industries, LP K230384PolyWear® 個人防護等級3袍子PolyConversions, Inc.

官方來源

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