FDA 510(k)

Remunity 泵用于Remodulin（曲前列素）注射剂

K号: K202690 · 2020-12-30

决定日期2020-12-30

产品代码QJY

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

Remunity Pump for Remodulin (treprostinil) Injection is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2020-12-30 under 510(k) number K202690. The device is classified under product code QJY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Remunity Pump for Remodulin (treprostinil) Injection?

Remunity Pump for Remodulin (treprostinil) Injection is a medical device that received FDA 510(k) clearance on 2020-12-30. The listed applicant is Deka Research and Development. The 510(k) number is K202690.

When did Remunity Pump for Remodulin (treprostinil) Injection receive FDA 510(k) clearance?

Remunity Pump for Remodulin (treprostinil) Injection received FDA 510(k) clearance on 2020-12-30, under 510(k) number K202690.

Who is the listed applicant for Remunity Pump for Remodulin (treprostinil) Injection?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Remunity Pump for Remodulin (treprostinil) Injection?

The FDA product code for Remunity Pump for Remodulin (treprostinil) Injection is QJY.

列明Deka Research and Development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。

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