FDA 510(k)

冲洗注射器（预充0.9%氯化钠溶液）

K号: K231724 · 2023-11-09

决定日期2023-11-09

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

Flush Syringe (Prefilled 0.9% normal saline solution) is the device name listed in this FDA 510(k) record. The listed applicant is Spm Medicare Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231724. 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 Flush Syringe (Prefilled 0.9% normal saline solution)?

Flush Syringe (Prefilled 0.9% normal saline solution) is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Spm Medicare Pvt. , Ltd.. The 510(k) number is K231724.

When did Flush Syringe (Prefilled 0.9% normal saline solution) receive FDA 510(k) clearance?

Flush Syringe (Prefilled 0.9% normal saline solution) received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231724.

Who is the listed applicant for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA 510(k) record lists Spm Medicare Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution) is NGT.

列明Spm Medicare Pvt. , 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。

K233794胰岛素注射器

相关器械（代码：NGT）

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。

K2508840.9%氯化钠注射剂，USP，BD PosiFlush® SP注射器Becton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231363Hantech 预充式 0.9% 生理盐水注射器（型号 PFS-1003, PFS-1005, PFS-1010）Hantech Medical Device Co., Ltd.K230756TK 预充生理盐水冲洗注射器Anhui Tiankang Medical Technology Co., Ltd.K223584预充生理盐水冲洗注射器Anhui Tianyang Pharmaceutical Co., Ltd.K2311610.9% 氯化钠注射剂，USP BD PosiFlush™ SF 盐水冲洗注射器Becton, Dickinson and Company

官方来源

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