FDA 510(k)

Cordless Prophy System, 型号: i-Polish

K号: K211531 · 2021-12-17

申请人Guilin Woodpecker Medical Instrument Co., Ltd.

决定日期2021-12-17

产品代码EKX

咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。

决定实质等同

器械摘要

Cordless Prophy System, Model: i-Polish is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K211531. 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 Cordless Prophy System, Model: i-Polish?

Cordless Prophy System, Model: i-Polish is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K211531.

When did Cordless Prophy System, Model: i-Polish receive FDA 510(k) clearance?

Cordless Prophy System, Model: i-Polish received FDA 510(k) clearance on 2021-12-17, under 510(k) number K211531.

Who is the listed applicant for Cordless Prophy System, Model: i-Polish?

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

What is the FDA product code for Cordless Prophy System, Model: i-Polish?

The FDA product code for Cordless Prophy System, Model: i-Polish is EKX.

列明Guilin Woodpecker Medical Instrument 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。

K251438牙科 X-Ray 设备 (Ai Ray Lite, Ai Ray Pro, Master Ray )K222569Ai Ray 牙科X射线设备 K211358植入器及附件 K221548牙科空气抛光手柄 K210367D-Laser Blue，D-Laser 16 K203706牙科电动马达

查看所有 11 个设备 →

官方来源

在 FDA 数据库中查看 →

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。