FDA 510(k)

塑料 LOR 注射器

K号: K201356 · 2021-02-12

决定日期2021-02-12

产品代码CAZ

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Plastic LOR Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K201356. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plastic LOR Syringe?

Plastic LOR Syringe is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K201356.

When did Plastic LOR Syringe receive FDA 510(k) clearance?

Plastic LOR Syringe received FDA 510(k) clearance on 2021-02-12, under 510(k) number K201356.

Who is the listed applicant for Plastic LOR Syringe?

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

What is the FDA product code for Plastic LOR Syringe?

The FDA product code for Plastic LOR Syringe is CAZ.

列明Jiangsu Caina Medical 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。

K232781安全滑动式血液采集套装 K233190ENFit 连接器 K230635笔式针头 K220184Pump Alignment Syringe K211593肠内泵注射器 K210217无针连接器

查看所有 15 个设备 →

官方来源

在 FDA 数据库中查看 →

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。