FDA 510(k)

U&U胰岛素注射器（带/不带安全可缩回装置）

K号: K152808 · 2016-03-25

决定日期2016-03-25

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

U&U Insulin Syringe with/without Safety Retractable Device is the device name listed in this FDA 510(k) record. The listed applicant is U&U Medical Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152808. 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 U&U Insulin Syringe with/without Safety Retractable Device?

U&U Insulin Syringe with/without Safety Retractable Device is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is U&U Medical Technology Co, Ltd.. The 510(k) number is K152808.

When did U&U Insulin Syringe with/without Safety Retractable Device receive FDA 510(k) clearance?

U&U Insulin Syringe with/without Safety Retractable Device received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152808.

Who is the listed applicant for U&U Insulin Syringe with/without Safety Retractable Device?

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

What is the FDA product code for U&U Insulin Syringe with/without Safety Retractable Device?

The FDA product code for U&U Insulin Syringe with/without Safety Retractable Device is MEG.

列明U&U 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。

K181508U&U 血液采集套装 K171823U&U 指示胶带和条带 K160855U&U 肠内注射器

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 Corporation K231907Medline 安全胰岛素和TB注射器Medline Industries, LP K223376Monoject 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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