FDA 510(k)

Cardinal Health SMARTGOWN 透气手术服，Cardinal Health SMARTGOWN AIR 透气手术服

K号: K200824 · 2020-07-29

决定日期2020-07-29

产品代码FYA

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决定实质等同

器械摘要

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown 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 2020-07-29 under 510(k) number K200824. 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 SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown?

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown is a medical device that received FDA 510(k) clearance on 2020-07-29. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K200824.

When did Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown receive FDA 510(k) clearance?

Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown received FDA 510(k) clearance on 2020-07-29, under 510(k) number K200824.

Who is the listed applicant for Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown?

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 Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown?

The FDA product code for Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown is FYA.

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

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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 Studio K252575Tuff 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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