FDA 510(k)

Remunity 系统

K号: K243354 · 2024-11-27

决定日期2024-11-27

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 System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research & Development Corp.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K243354. 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 System?

Remunity System is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Deka Research & Development Corp.. The 510(k) number is K243354.

When did Remunity System receive FDA 510(k) clearance?

Remunity System received FDA 510(k) clearance on 2024-11-27, under 510(k) number K243354.

Who is the listed applicant for Remunity System?

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

What is the FDA product code for Remunity System?

The FDA product code for Remunity System is QJY.

列明Deka Research & Development Corp.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。

K250930twiist系统 K250357RemunityPRO® 泵用于Remodulin®（曲前列素）注射剂 K241736Remunity 2.0 泵用于Remodulin（曲前列素）注射剂 K172601下一代 iBOT

官方来源

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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。