FDA 510(k)

Unity 皮下输液系统（Remodulin）

K号: K191313 · 2020-02-21

决定日期2020-02-21

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

Unity Subcutaneous Infusion System for Remodulin is the device name listed in this FDA 510(k) record. The listed applicant is DEKA Research & Development. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K191313. 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 Unity Subcutaneous Infusion System for Remodulin?

Unity Subcutaneous Infusion System for Remodulin is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is DEKA Research & Development. The 510(k) number is K191313.

When did Unity Subcutaneous Infusion System for Remodulin receive FDA 510(k) clearance?

Unity Subcutaneous Infusion System for Remodulin received FDA 510(k) clearance on 2020-02-21, under 510(k) number K191313.

Who is the listed applicant for Unity Subcutaneous Infusion System for Remodulin?

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

What is the FDA product code for Unity Subcutaneous Infusion System for Remodulin?

The FDA product code for Unity Subcutaneous Infusion System for Remodulin is QJY.

列明DEKA Research & Development为申报人的其他记录

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官方来源

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