FDA 510(k)

ABSOLU

K号: K183414 · 2019-03-20

决定日期2019-03-20

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

ABSOLU is the device name listed in this FDA 510(k) record. The listed applicant is Quantel Medical. It received FDA 510(k) clearance on 2019-03-20 under 510(k) number K183414. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ABSOLU?

ABSOLU is a medical device that received FDA 510(k) clearance on 2019-03-20. The listed applicant is Quantel Medical. The 510(k) number is K183414.

When did ABSOLU receive FDA 510(k) clearance?

ABSOLU received FDA 510(k) clearance on 2019-03-20, under 510(k) number K183414.

Who is the listed applicant for ABSOLU?

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

What is the FDA product code for ABSOLU?

The FDA product code for ABSOLU is IYO.

列明Quantel Medical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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