FDA 510(k)

Luminoah FLOW™ 肠内营养系统

K号: K253558 · 2026-04-20

决定日期2026-04-20

产品代码LZH

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Luminoah FLOW™ Enteral Nutrition System is the device name listed in this FDA 510(k) record. The listed applicant is Luminoah. It received FDA 510(k) clearance on 2026-04-20 under 510(k) number K253558. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Luminoah FLOW™ Enteral Nutrition System?

Luminoah FLOW™ Enteral Nutrition System is a medical device that received FDA 510(k) clearance on 2026-04-20. The listed applicant is Luminoah. The 510(k) number is K253558.

When did Luminoah FLOW™ Enteral Nutrition System receive FDA 510(k) clearance?

Luminoah FLOW™ Enteral Nutrition System received FDA 510(k) clearance on 2026-04-20, under 510(k) number K253558.

Who is the listed applicant for Luminoah FLOW™ Enteral Nutrition System?

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

What is the FDA product code for Luminoah FLOW™ Enteral Nutrition System?

The FDA product code for Luminoah FLOW™ Enteral Nutrition System is LZH.

相关器械（代码：LZH）

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。

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。

器械摘要

常见问题

相关临床试验

相关器械（代码：LZH）

官方来源