FDA 510(k)

Hantech 预充式 0.9% 生理盐水注射器（型号 PFS-1003, PFS-1005, PFS-1010）

K号: K231363 · 2023-09-27

决定日期2023-09-27

产品代码NGT

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

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is the device name listed in this FDA 510(k) record. The listed applicant is Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) number K231363. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K231363.

When did Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) receive FDA 510(k) clearance?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) received FDA 510(k) clearance on 2023-09-27, under 510(k) number K231363.

Who is the listed applicant for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

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

What is the FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

The FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is NGT.

列明Hantech Medical Device 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。

K222739一次性胰岛素笔针 K222672一次性胰岛素注射器 K221038一次性医用口罩 K220603一次性医用安全注射针

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