FDA 510(k)

ABL90 FLEX PLUS 系统

K号: K241037 · 2025-01-14

决定日期2025-01-14

产品代码CEM

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决定实质等同

器械摘要

ABL90 FLEX PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer Medicals Aps. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K241037. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ABL90 FLEX PLUS System?

ABL90 FLEX PLUS System is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Radiometer Medicals Aps. The 510(k) number is K241037.

When did ABL90 FLEX PLUS System receive FDA 510(k) clearance?

ABL90 FLEX PLUS System received FDA 510(k) clearance on 2025-01-14, under 510(k) number K241037.

Who is the listed applicant for ABL90 FLEX PLUS System?

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

What is the FDA product code for ABL90 FLEX PLUS System?

The FDA product code for ABL90 FLEX PLUS System is CEM.

列明Radiometer Medicals Aps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。

K252475ABL90 FLEX PLUS 系统 K252488ABL90 FLEX PLUS 系统 K252207ABL90 FLEX PLUS 系统，safeCLINITUBES K240998ABL90 FLEX PLUS 系统

官方来源

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