TotalShield II 外科安全帽系統
K 號：K192194 · 2019-10-15
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器材摘要
TotalShield II Surgical Helmet System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) number K192194. 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 TotalShield II Surgical Helmet System?
TotalShield II Surgical Helmet System is a medical device that received FDA 510(k) clearance on 2019-10-15. The listed applicant is Zimmer Surgical, Inc.. The 510(k) number is K192194.
When did TotalShield II Surgical Helmet System receive FDA 510(k) clearance?
TotalShield II Surgical Helmet System received FDA 510(k) clearance on 2019-10-15, under 510(k) number K192194.
Who is the listed applicant for TotalShield II Surgical Helmet System?
The FDA 510(k) record lists Zimmer Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TotalShield II Surgical Helmet System?
The FDA product code for TotalShield II Surgical Helmet System is FYA.
相關臨床試驗
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。
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 StudioK252575Tuff 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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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