FDA 510(k)

AAMI 级别 4 保护服；外衣

K号: K242689 · 2025-01-13

决定日期2025-01-13

产品代码QPC

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

AAMI Level 4 Protective; Gown is the device name listed in this FDA 510(k) record. The listed applicant is Azac Group. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K242689. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AAMI Level 4 Protective; Gown?

AAMI Level 4 Protective; Gown is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Azac Group. The 510(k) number is K242689.

When did AAMI Level 4 Protective; Gown receive FDA 510(k) clearance?

AAMI Level 4 Protective; Gown received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242689.

Who is the listed applicant for AAMI Level 4 Protective; Gown?

The FDA 510(k) record lists Azac Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AAMI Level 4 Protective; Gown?

The FDA product code for AAMI Level 4 Protective; Gown is QPC.

列明Azac Group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。

K211538Protect X 级别3隔离服

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。