FDA 510(k)

ERBEJET® 2 系统

K号: K231023 · 2023-06-15

决定日期2023-06-15

产品代码FQH

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

ERBEJET® 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K231023. The device is classified under product code FQH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ERBEJET® 2 System?

ERBEJET® 2 System is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K231023.

When did ERBEJET® 2 System receive FDA 510(k) clearance?

ERBEJET® 2 System received FDA 510(k) clearance on 2023-06-15, under 510(k) number K231023.

Who is the listed applicant for ERBEJET® 2 System?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERBEJET® 2 System?

The FDA product code for ERBEJET® 2 System is FQH.

列明Erbe Elektromedizin GmbH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。

K261806ERBECRYO 2 冷冻手术单元及附件 K253230ERBECRYO 2 冷冻手术单元及附件：ERBECRYO 2 冷冻手术单元；Erbe 弹性冷冻探头 K253915MOVIVA® 混合消融探头 K251108Erbe ESU 型号 VIO® 3n 及附件 K243120混合APC探头 K243451FiAPC plus探头

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官方来源

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