FDA 510(k)

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）

K号: K181426 · 2018-10-11

申请人Jiangsu Micsafe Medical Technology Co., Ltd.

决定日期2018-10-11

产品代码PNR

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决定实质等同

器械摘要

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) 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 2018-10-11 under 510(k) number K181426. The device is classified under product code PNR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K181426.

When did Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) receive FDA 510(k) clearance?

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) received FDA 510(k) clearance on 2018-10-11, under 510(k) number K181426.

Who is the listed applicant for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

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 Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)?

The FDA product code for Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) is PNR.

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 Mask K183665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

相关器械（代码：PNR）

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。

K252483肠内注射器（20ml，60ml）Chirana T.Injecta,A.S.K253268Profoject 鼻饲/口饲注射器；Profoject 可重复使用鼻饲/口饲注射器（型号A，型号B）；Profoject ENFit 连接器；Profoject 鼻饲注射器盖CMT Health PTE., Ltd.K251585Profoject™ 鼻饲注射器CMT Health PTE., Ltd.K243652Monoject® Enteral Syringe with ENFit Connector (401SE); Monoject® Enteral Syringe with ENFit Connector (403SE); Monoject® Enteral Syringe with ENFit Connector (406SE); Monoject® Enteral Syringe with ENFit Connector (412SE); Monoject® Enteral Syringe with ENFit Connector (435SE); Monoject® Enteral Syringe with ENFit Connector (460SE)Cardinalhealth K231300Nutricair Enteral Syringe with ENFitCair Lgl K222772带ENFit连接器的口腔/肠内注射器Anhui Tiankang Medical Technology Co., Ltd.

官方来源

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