FDA 510(k)

卡迪那爾健康™ 智能袍™ EDGE 通氣外科袍，配備 ASSIST™ 工具口袋

K 號：K230838 · 2023-07-27

決定日期2023-07-27

產品代碼FYA

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 Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets 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 2023-07-27 under 510(k) number K230838. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets?

Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets is a medical device that received FDA 510(k) clearance on 2023-07-27. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K230838.

When did Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets receive FDA 510(k) clearance?

Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets received FDA 510(k) clearance on 2023-07-27, under 510(k) number K230838.

Who is the listed applicant for Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets?

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 Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets?

The FDA product code for Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets is FYA.

其他以 Cardinal Health200, LLC 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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查看所有 14 項裝置 →

相關器械（代碼：FYA）

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。

K260407原則與願景 ANSI/AAMI PB 70（無菌/非无菌）第3級外科袍（加強型）以及原則與願景 ANSI/AMMI PB70（無菌/非无菌）第4級外科袍/隔離袍Principle & Will Co., Ltd.K261028外科袍等級2（S，M，L，XL，XXL，XXXL）Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 一次性袍子New York Embroidery Studio K252575Tuff Cuff™ 一次性外科袍 AAMI L4 無菌-大號 (ML-L4-STL-DC-L)New York Embroidery Studio (NYES)K260725BAÜMER 外科袍 (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V.K253243卡迪那爾健康™多層加強外科袍Cardinal Health 200, LLC

官方來源

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