FDA 510(k)

E-connect S Endo Motor with built-in Apex Locator

K号: K201993 · 2021-01-29

申请人Changzhou Sifary Medical Technology Co., Ltd.

决定日期2021-01-29

产品代码EKX

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决定实质等同

器械摘要

E-connect S Endo Motor with built-in Apex Locator is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K201993. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the E-connect S Endo Motor with built-in Apex Locator?

E-connect S Endo Motor with built-in Apex Locator is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K201993.

When did E-connect S Endo Motor with built-in Apex Locator receive FDA 510(k) clearance?

E-connect S Endo Motor with built-in Apex Locator received FDA 510(k) clearance on 2021-01-29, under 510(k) number K201993.

Who is the listed applicant for E-connect S Endo Motor with built-in Apex Locator?

FDA 510(k)记录将常州思法瑞医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for E-connect S Endo Motor with built-in Apex Locator?

The FDA product code for E-connect S Endo Motor with built-in Apex Locator is EKX.

列明Changzhou Sifary Medical Technology Co., Ltd.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。

K260795手持式牙科X射线系统（HyperLight-M）K252224Apex定位器（FindPex）K232068HyperLight 便携式X射线单元 K221152CuringPen Dental Curing Light

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。