FDA 510(k)

Cercare 医疗神经套件（CMN）毛细血管功能与虚拟专家

K号: K241989 · 2024-12-06

决定日期2024-12-06

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is the device name listed in this FDA 510(k) record. The listed applicant is Cercare Medical A/S. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K241989. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert?

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Cercare Medical A/S. The 510(k) number is K241989.

When did Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert receive FDA 510(k) clearance?

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241989.

Who is the listed applicant for Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert?

The FDA 510(k) record lists Cercare Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert?

The FDA product code for Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is LLZ.

列明Cercare Medical A/S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。

K260316CMN 毛细血管功能与肿瘤学虚拟专家 K253831CMN 毛细血管功能与虚拟专家用于 MRI、CT 和 CBCT K230016Cercare 医疗神经套件

官方来源

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