FDA 510(k)

MED RF 4000

K号: K210077 · 2021-12-17

决定日期2021-12-17

产品代码ONQ

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决定实质等同

器械摘要

MED RF 4000 is the device name listed in this FDA 510(k) record. The listed applicant is F Care Systems USA, LLC. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210077. The device is classified under product code ONQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MED RF 4000?

MED RF 4000 is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is F Care Systems USA, LLC. The 510(k) number is K210077.

When did MED RF 4000 receive FDA 510(k) clearance?

MED RF 4000 received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210077.

Who is the listed applicant for MED RF 4000?

The FDA 510(k) record lists F Care Systems USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED RF 4000?

The FDA product code for MED RF 4000 is ONQ.

列明F Care Systems USA, 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。

K253918维纳欧系统（00MEDRF4000TCUS 05CR45iT 06Pedal1St）K252704F Care射频系统（00MEDRF4000US，05RAFAELOPROBE，05SPHERAPROBE，06OUTPUTKAB，06Pedal1St）K220725HPR45i

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。