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FDA 510(k)

Cardinal Health ChemoPlus 全覆盖工作服，封闭背部，Cardinal Health ChemoPlus 全覆盖工作服，开放背部，Cardinal Health ChemoPlus 全覆盖袖子

K号: K193327 · 2020-03-20

申请人Cardinal Health200, LLC
决定日期2020-03-20
产品代码FYA
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve 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 2020-03-20 under 510(k) number K193327. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K193327.

When did Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve receive FDA 510(k) clearance?

Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193327.

Who is the listed applicant for Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

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 ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve?

The FDA product code for Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve is FYA.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Cardinal Health200, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241780Cardinal Health 氮化橡胶检查手套K230838Cardinal Health™ SmartGown™ EDGE透气手术服，带ASSIST™工具口袋K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow 控制器，Cardinal Health Element 空气袖，Kendall SCD Express 空气袖，Kendall SCD Express 足部袖，Kendall SCD 顺序压缩舒适袖，Kendall SCD SmartFlow 控制器管路组件K201592Cardinal Health Protexis PI Blue with Neu-Thera 手术手套K211390乳胶蓝无粉检查手套

查看所有 14 个设备 →

相关器械（代码：FYA）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260407原理与意愿 ANSI/AAMI PB 70（无菌/非无菌）三级手术服（加固型）和原理与意愿 ANSI/AMMI PB70（无菌/非无菌）四级手术服/隔离服Principle & Will Co., Ltd.K261028手术服 Level2（S，M，L，XL，XXL，XXXL）Yadu Medical (Henan) Co., Ltd.K261949NYES Tuff Cuff L3 一次性隔离衣New York Embroidery StudioK252575Tuff Cuff™ 一次性手术服 AAMI L4 灭菌-大号（ML-L4-STL-DC-L）New York Embroidery Studio (NYES)K260725BAÜMER 手术服（COP01, COP04, COP05, COP10）Hindernis DE Mexico, S.A.P.I. DE C.V.K253243Cardinal Health™聚酯增强手术服Cardinal Health 200, LLC

官方来源

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