FDA 510(k)

超声肠内激活装置（型号：Actor I pro）

K号: K213947 · 2022-09-08

申请人Changzhou Bomedent Medical Technology Co.,Ltd

决定日期2022-09-08

产品代码ELC

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决定实质等同

器械摘要

Ultrasonic Endo Activation Device (Model:Actor I pro) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2022-09-08 under 510(k) number K213947. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasonic Endo Activation Device (Model:Actor I pro)?

Ultrasonic Endo Activation Device (Model:Actor I pro) is a medical device that received FDA 510(k) clearance on 2022-09-08. The listed applicant is Changzhou Bomedent Medical Technology Co.,Ltd. The 510(k) number is K213947.

When did Ultrasonic Endo Activation Device (Model:Actor I pro) receive FDA 510(k) clearance?

Ultrasonic Endo Activation Device (Model:Actor I pro) received FDA 510(k) clearance on 2022-09-08, under 510(k) number K213947.

Who is the listed applicant for Ultrasonic Endo Activation Device (Model:Actor I pro)?

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

What is the FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro)?

The FDA product code for Ultrasonic Endo Activation Device (Model:Actor I pro) is ELC.

列明Changzhou Bomedent 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。

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相关器械（代码：ELC）

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。

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