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FDA 510(k)

安全注射针，无菌注射器，带安全注射针的无菌注射器，带针的无菌注射器，一次性皮下注射针

K号: K183665 · 2019-09-06

申请人Jiangsu Micsafe Medical Technology Co., Ltd.
决定日期2019-09-06
产品代码MEG
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

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K183665. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K183665.

When did Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use receive FDA 510(k) clearance?

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use received FDA 510(k) clearance on 2019-09-06, under 510(k) number K183665.

Who is the listed applicant for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

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

What is the FDA product code for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use?

The FDA product code for Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use is MEG.

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

列明Jiangsu Micsafe 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。

K212019一次性使用血液采集针及带针座的血液采集针，一次性使用安全血液采集针及带针座的安全血液采集针，一次性使用血液采集套装及带针座的安全血液采集套装，一次性使用安全血液采集套装及带针座的血液采集套装K202570胰岛素注射器，带安全可回缩的胰岛素注射器K202205Surgical Face MaskK181426口腔/肠内注射器（10 mL至60 mL）和低剂量尖端口腔/肠内注射器（1 mL至5 mL）

相关器械（代码：MEG）

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。

K252098PA3X可拆卸安全套筒注射器（带针）（SC-23ED / SD-23ED）Methyl Co., Ltd.K250847蒸汽盾Vault Paragon Group, Inc.K230287SaviSafe 安全设备Suzhou Savicred Biotechnology Co., Ltd.K231165Shina 注射器; Shina 安全注射器Shina Med CorporationK231907Medline 安全胰岛素和TB注射器Medline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

官方来源

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