FDA 510(k)

MStim Drop Model: LGT-233

K号: K202110 · 2021-11-05

申请人Guangzhou Longest Science & Technology Co., Ltd.

决定日期2021-11-05

产品代码GZI

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

MStim Drop Model: LGT-233 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-05 under 510(k) number K202110. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MStim Drop Model: LGT-233?

MStim Drop Model: LGT-233 is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Guangzhou Longest Science & Technology Co., Ltd.. The 510(k) number is K202110.

When did MStim Drop Model: LGT-233 receive FDA 510(k) clearance?

MStim Drop Model: LGT-233 received FDA 510(k) clearance on 2021-11-05, under 510(k) number K202110.

Who is the listed applicant for MStim Drop Model: LGT-233?

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

What is the FDA product code for MStim Drop Model: LGT-233?

The FDA product code for MStim Drop Model: LGT-233 is GZI.

列明Guangzhou Longest Science & 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。

K201845便携式电刺激治疗设备，型号：LGT-232(US)K182020便携式电刺激治疗设备 K191856压缩治疗设备 K191862压缩治疗设备型号LGT-2200SP K182108便携式电刺激治疗设备

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