FDA 510(k)

一次性隔离服

K号: K223467 · 2023-02-10

申请人Nanning Tecbod Biological Technology Co., Ltd.

决定日期2023-02-10

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

Disposable Isolation Gown is the device name listed in this FDA 510(k) record. The listed applicant is Nanning Tecbod Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K223467. 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 Disposable Isolation Gown?

Disposable Isolation Gown is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Nanning Tecbod Biological Technology Co., Ltd.. The 510(k) number is K223467.

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

Disposable Isolation Gown received FDA 510(k) clearance on 2023-02-10, under 510(k) number K223467.

Who is the listed applicant for Disposable Isolation Gown?

The FDA 510(k) record lists Nanning Tecbod Biological Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Isolation Gown?

The FDA product code for Disposable Isolation Gown is FYC.

列明Nanning Tecbod Biological Technology Co., Ltd.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。

K233068一次性手术服

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.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 K210414CoverU带胶纸一次性隔离服AAMI Level 4隔离服CoverU带胶纸一次性隔离服 - 化疗服Medtecs (Taiwan) Corp.

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。