FDA 510(k)

Cardinal Health 隔离工作服

K号: K160339 · 2016-07-28

决定日期2016-07-28

产品代码FYC

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 Isolation 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 2016-07-28 under 510(k) number K160339. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardinal Health Isolation Gown?

Cardinal Health Isolation Gown is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K160339.

When did Cardinal Health Isolation Gown receive FDA 510(k) clearance?

Cardinal Health Isolation Gown received FDA 510(k) clearance on 2016-07-28, under 510(k) number K160339.

Who is the listed applicant for Cardinal Health Isolation 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 Isolation Gown?

The FDA product code for Cardinal Health Isolation Gown is FYC.

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：FYC）

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。

K232849Halyard Tri-Layer AAMI 3隔离服，L，蓝色（54310），Halyard Tri-Layer AAMI 3隔离服，超大号，蓝色（54311）Owens & Minor (O&M) Halyard, Inc.K230135Copioumed 化疗隔离服Copioumed International, Inc.K223467一次性隔离服Nanning Tecbod Biological Technology Co., Ltd.K223304一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Technology Co., Ltd.K223411一次性隔离服（S，M，L，XL，XXL，XXXL）Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI等级3隔离服Paneffort, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。