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FDA 510(k)

带ENFit连接器的口腔/肠内注射器(12 mL至60 mL),带ENFit连接器的低剂量尖端口腔/肠内注射器(1 mL至6 mL)

K号: K183540 · 2019-04-30

申请人Neomed, Inc.
决定日期2019-04-30
产品代码PNR
咨询委员会GU 请注意,由于您只提供了“GU”这个词,我无法提供完整的翻译。如果您能提供完整的句子或段落,我将能够为您提供准确的翻译。
决定实质等同

器械摘要

Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) is the device name listed in this FDA 510(k) record. The listed applicant is Neomed, Inc.. It received FDA 510(k) clearance on 2019-04-30 under 510(k) number K183540. 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 Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)?

Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) is a medical device that received FDA 510(k) clearance on 2019-04-30. The listed applicant is Neomed, Inc.. The 510(k) number is K183540.

When did Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) receive FDA 510(k) clearance?

Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) received FDA 510(k) clearance on 2019-04-30, under 510(k) number K183540.

Who is the listed applicant for Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)?

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

What is the FDA product code for Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)?

The FDA product code for Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) is PNR.

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。

列明Neomed, 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。

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。

官方来源

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