FDA 510(k)

TK 预充生理盐水冲洗注射器

K号: K230756 · 2023-08-12

申请人Anhui Tiankang Medical Technology Co., Ltd.

决定日期2023-08-12

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

TK Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-12 under 510(k) number K230756. 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 TK Pre-Filled Normal Saline Flush Syringe?

TK Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2023-08-12. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K230756.

When did TK Pre-Filled Normal Saline Flush Syringe receive FDA 510(k) clearance?

TK Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2023-08-12, under 510(k) number K230756.

Who is the listed applicant for TK Pre-Filled Normal Saline Flush Syringe?

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

What is the FDA product code for TK Pre-Filled Normal Saline Flush Syringe?

The FDA product code for TK Pre-Filled Normal Saline Flush Syringe is NGT.

列明Anhui Tiankang Medical 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。

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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.K231724冲洗注射器（预充0.9%氯化钠溶液）Spm Medicare Pvt. , Ltd.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.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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