FDA 510(k)

Praxiject 0.9% NaCl

K号: K192414 · 2020-02-13

决定日期2020-02-13

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

Praxiject 0.9% NaCl is the device name listed in this FDA 510(k) record. The listed applicant is Medxl, Inc.. It received FDA 510(k) clearance on 2020-02-13 under 510(k) number K192414. 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 Praxiject 0.9% NaCl?

Praxiject 0.9% NaCl is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is Medxl, Inc.. The 510(k) number is K192414.

When did Praxiject 0.9% NaCl receive FDA 510(k) clearance?

Praxiject 0.9% NaCl received FDA 510(k) clearance on 2020-02-13, under 510(k) number K192414.

Who is the listed applicant for Praxiject 0.9% NaCl?

The FDA 510(k) record lists Medxl, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Praxiject 0.9% NaCl?

The FDA product code for Praxiject 0.9% NaCl is NGT.

列明Medxl, Inc.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。

K233623Praxiject™ SP 0.9% NaCl K231754Praxiject™ 0.9% NaCl K171109Praxiject 0.9% NaCl

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.K230756TK 预充生理盐水冲洗注射器Anhui Tiankang Medical Technology Co., Ltd.

官方来源

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