FDA 510(k)

Hyperion X9 pro，NewTom GiANO HR，X-RADiUS TRiO PLUS

K号: K214084 · 2022-01-20

决定日期2022-01-20

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K214084. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Cefla S.C.. The 510(k) number is K214084.

When did hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS receive FDA 510(k) clearance?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS received FDA 510(k) clearance on 2022-01-20, under 510(k) number K214084.

Who is the listed applicant for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

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

What is the FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS?

The FDA product code for hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is OAS.

列明Cefla S.C.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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