FDA 510(k)

CeQur Simplicity™ 需求胰岛素输送系统

K号: K252757 · 2026-04-10

决定日期2026-04-10

产品代码OPP

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

CeQur Simplicity™ On-Demand Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Cequr SA. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252757. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CeQur Simplicity™ On-Demand Insulin Delivery System?

CeQur Simplicity™ On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Cequr SA. The 510(k) number is K252757.

When did CeQur Simplicity™ On-Demand Insulin Delivery System receive FDA 510(k) clearance?

CeQur Simplicity™ On-Demand Insulin Delivery System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252757.

Who is the listed applicant for CeQur Simplicity™ On-Demand Insulin Delivery System?

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

What is the FDA product code for CeQur Simplicity™ On-Demand Insulin Delivery System?

The FDA product code for CeQur Simplicity™ On-Demand Insulin Delivery System is OPP.

列明Cequr SA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。

K243273CeQur Simplicity™ 需求胰岛素输送系统 K233447CeQur Simplicity™ 需求胰岛素输送系统

官方来源

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