FDA 510(k)

Skypro, 外科袍 6021

K 號：K230707 · 2023-10-12

決定日期2023-10-12

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

Skypro, Surgical Gown 6021 is the device name listed in this FDA 510(k) record. The listed applicant is Skypro Medical Supplies Company. It received FDA 510(k) clearance on 2023-10-12 under 510(k) number K230707. 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 Skypro, Surgical Gown 6021?

Skypro, Surgical Gown 6021 is a medical device that received FDA 510(k) clearance on 2023-10-12. The listed applicant is Skypro Medical Supplies Company. The 510(k) number is K230707.

When did Skypro, Surgical Gown 6021 receive FDA 510(k) clearance?

Skypro, Surgical Gown 6021 received FDA 510(k) clearance on 2023-10-12, under 510(k) number K230707.

Who is the listed applicant for Skypro, Surgical Gown 6021?

The FDA 510(k) record lists Skypro Medical Supplies Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skypro, Surgical Gown 6021?

The FDA product code for Skypro, Surgical Gown 6021 is FYA.

其他以 Skypro Medical Supplies Company 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。

K202255Skypro, SP02 面罩（3）K152197Skypro, SP01 面罩

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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