FDA 510(k)

医疗一次性无菌针电极

K号: K232581 · 2023-12-04

申请人Suzhou Haishen Medical Device Associates Co., Ltd.

决定日期2023-12-04

产品代码GXZ

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

Medical Disposable Sterile Needle Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K232581. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medical Disposable Sterile Needle Electrode?

Medical Disposable Sterile Needle Electrode is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Suzhou Haishen Medical Device Associates Co., Ltd.. The 510(k) number is K232581.

When did Medical Disposable Sterile Needle Electrode receive FDA 510(k) clearance?

Medical Disposable Sterile Needle Electrode received FDA 510(k) clearance on 2023-12-04, under 510(k) number K232581.

Who is the listed applicant for Medical Disposable Sterile Needle Electrode?

The FDA 510(k) record lists Suzhou Haishen Medical Device Associates Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Disposable Sterile Needle Electrode?

The FDA product code for Medical Disposable Sterile Needle Electrode is GXZ.

列明Suzhou Haishen Medical Device Associates 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。

K232888一次性喉部电极

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