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FDA 510(k)

0.9% 氯化钠 I.V. 冲洗注射器，1 支/袋，0.9% 氯化钠 I.V. 冲洗注射器，2 支/袋

K号: K201286 · 2020-08-11

申请人Nurse Assist, LLC
决定日期2020-08-11
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

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch is the device name listed in this FDA 510(k) record. The listed applicant is Nurse Assist, LLC. It received FDA 510(k) clearance on 2020-08-11 under 510(k) number K201286. 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 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch?

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch is a medical device that received FDA 510(k) clearance on 2020-08-11. The listed applicant is Nurse Assist, LLC. The 510(k) number is K201286.

When did 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch receive FDA 510(k) clearance?

0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch received FDA 510(k) clearance on 2020-08-11, under 510(k) number K201286.

Who is the listed applicant for 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch?

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

What is the FDA product code for 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch?

The FDA product code for 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch is NGT.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 CompanyK233623Praxiject™ 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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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