FDA 510(k)

Overjet 结石辅助

K号: K220928 · 2022-12-16

决定日期2022-12-16

产品代码MYN

咨询委员会RA

决定实质等同

器械摘要

Overjet Calculus Assist is the device name listed in this FDA 510(k) record. The listed applicant is Overjet, Inc.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220928. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Overjet Calculus Assist?

Overjet Calculus Assist is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Overjet, Inc.. The 510(k) number is K220928.

When did Overjet Calculus Assist receive FDA 510(k) clearance?

Overjet Calculus Assist received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220928.

Who is the listed applicant for Overjet Calculus Assist?

FDA 510(k)记录中列出Overjet, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Overjet Calculus Assist?

The FDA product code for Overjet Calculus Assist is MYN.

列明Overjet, Inc.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。

K261059Overjet 多图像龋齿和图表辅助设备 K253930Overjet 瞳孔智能成像系统 K251514Overjet CBCT 辅助 K241681Overjet 图像增强辅助 K241684Overjet 绘图辅助 K233738Overjet 龋齿辅助-儿科

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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。