FDA 510(k)

Aero Chrome* 通氣性能外科袍

K 號：K153255 · 2016-04-13

決定日期2016-04-13

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

Aero Chrome* Breathable Performance Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health, Inc.. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K153255. 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 Aero Chrome* Breathable Performance Surgical Gown?

Aero Chrome* Breathable Performance Surgical Gown is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is Halyard Health, Inc.. The 510(k) number is K153255.

When did Aero Chrome* Breathable Performance Surgical Gown receive FDA 510(k) clearance?

Aero Chrome* Breathable Performance Surgical Gown received FDA 510(k) clearance on 2016-04-13, under 510(k) number K153255.

Who is the listed applicant for Aero Chrome* Breathable Performance Surgical Gown?

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

What is the FDA product code for Aero Chrome* Breathable Performance Surgical Gown?

The FDA product code for Aero Chrome* Breathable Performance Surgical Gown is FYA.

其他以 Halyard Health, Inc. 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。

K173955麥凱* 靜脈導管式造口測量設備 K162930Aero Chrome* Select 通氣性能外科袍 K163461Coolief* 冷卻式RF探針 K163236COOLIEF 冷卻式電波刀組套件

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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