FDA 510(k)

A5 麻醉系统（A5）；A7 麻醉系统（A7）

K号: K253330 · 2026-06-25

申请人Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

决定日期2026-06-25

产品代码BSZ

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

A5 Anesthesia System (A5); A7 Anesthesia System (A7) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K253330. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the A5 Anesthesia System (A5); A7 Anesthesia System (A7)?

A5 Anesthesia System (A5); A7 Anesthesia System (A7) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K253330.

When did A5 Anesthesia System (A5); A7 Anesthesia System (A7) receive FDA 510(k) clearance?

A5 Anesthesia System (A5); A7 Anesthesia System (A7) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253330.

Who is the listed applicant for A5 Anesthesia System (A5); A7 Anesthesia System (A7)?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A5 Anesthesia System (A5); A7 Anesthesia System (A7)?

The FDA product code for A5 Anesthesia System (A5); A7 Anesthesia System (A7) is BSZ.

列明Shenzhen Mindray Bio-Medical Electronics 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。

查看所有 88 个设备 →

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。