FDA 510(k)

超声手术吸引器系统，型号：XD880B

K号: K212750 · 2021-09-27

决定日期2021-09-27

产品代码LFL

决定实质等同

器械摘要

Ultrasonic Surgical Aspirator System, Model: XD880B is the device name listed in this FDA 510(k) record. The listed applicant is Smtp Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-27 under 510(k) number K212750. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

常见问题

What is the Ultrasonic Surgical Aspirator System, Model: XD880B?

Ultrasonic Surgical Aspirator System, Model: XD880B is a medical device that received FDA 510(k) clearance on 2021-09-27. The listed applicant is Smtp Technology Co., Ltd.. The 510(k) number is K212750.

When did Ultrasonic Surgical Aspirator System, Model: XD880B receive FDA 510(k) clearance?

Ultrasonic Surgical Aspirator System, Model: XD880B received FDA 510(k) clearance on 2021-09-27, under 510(k) number K212750.

Who is the listed applicant for Ultrasonic Surgical Aspirator System, Model: XD880B?

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

What is the FDA product code for Ultrasonic Surgical Aspirator System, Model: XD880B?

The FDA product code for Ultrasonic Surgical Aspirator System, Model: XD880B is LFL.

列明Smtp 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。

K202299超声波手术吸引器系统 K201274超声骨切割手术系统

相关器械（代码：LFL）

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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官方来源

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