FDA 510(k)

HWJECT自动失效注射器

K号: K234024 · 2024-03-19

申请人Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

决定日期2024-03-19

产品代码FMF

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

HWJECT Auto-disable syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. It received FDA 510(k) clearance on 2024-03-19 under 510(k) number K234024. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HWJECT Auto-disable syringe?

HWJECT Auto-disable syringe is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. The 510(k) number is K234024.

When did HWJECT Auto-disable syringe receive FDA 510(k) clearance?

HWJECT Auto-disable syringe received FDA 510(k) clearance on 2024-03-19, under 510(k) number K234024.

Who is the listed applicant for HWJECT Auto-disable syringe?

The FDA 510(k) record lists Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HWJECT Auto-disable syringe?

The FDA product code for HWJECT Auto-disable syringe is FMF.