FDA 510(k)

DRSplus

K号: K213705 · 2021-12-21

决定日期2021-12-21

产品代码MYC

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决定实质等同

器械摘要

DRSplus is the device name listed in this FDA 510(k) record. The listed applicant is Centervue S.P.A.. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213705. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DRSplus?

DRSplus is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Centervue S.P.A.. The 510(k) number is K213705.

When did DRSplus receive FDA 510(k) clearance?

DRSplus received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213705.

Who is the listed applicant for DRSplus?

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

What is the FDA product code for DRSplus?

The FDA product code for DRSplus is MYC.

列明Centervue S.P.A.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。

K243504MAIA (AHMACME001)K234076iCare ALTIUS CW K211328EIDON FA，EIDON，EIDON AF，EIDON UWFL K192113DRSplus K180526EIDON FA K180293Retia 2

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。