FDA 510(k)

ALARA BMA神经接入套件（ALARA BMAN和ALARA BMAC套件）

K号: K240664 · 2024-08-09

决定日期2024-08-09

产品代码KNW

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决定实质等同

器械摘要

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2024-08-09 under 510(k) number K240664. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is a medical device that received FDA 510(k) clearance on 2024-08-09. The listed applicant is SurGenTec, LLC. The 510(k) number is K240664.

When did ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) receive FDA 510(k) clearance?

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) received FDA 510(k) clearance on 2024-08-09, under 510(k) number K240664.

Who is the listed applicant for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

FDA 510(k)记录中列出SurGenTec, LLC为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)?

The FDA product code for ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is KNW.

列明SurGenTec, LLC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。

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相关器械（代码：KNW）

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。

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官方来源

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