FDA 510(k)

牙科植入系统，牙科电动马达

K号: K220831 · 2022-09-27

申请人Foshan Coxo Medical Instrument Co., Ltd.

决定日期2022-09-27

产品代码EBW

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决定实质等同

器械摘要

Dental Implantation Systems, Dental Electrical Motors is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K220831. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dental Implantation Systems, Dental Electrical Motors?

Dental Implantation Systems, Dental Electrical Motors is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K220831.

When did Dental Implantation Systems, Dental Electrical Motors receive FDA 510(k) clearance?

Dental Implantation Systems, Dental Electrical Motors received FDA 510(k) clearance on 2022-09-27, under 510(k) number K220831.

Who is the listed applicant for Dental Implantation Systems, Dental Electrical Motors?

The FDA 510(k) record lists Foshan Coxo Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implantation Systems, Dental Electrical Motors?

The FDA product code for Dental Implantation Systems, Dental Electrical Motors is EBW.

列明Foshan Coxo Medical Instrument Co., Ltd.为申报人的其他记录

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