FDA 510(k)

Life Ultra 25L 台式单室蒸汽灭菌器

K号: K250168 · 2025-12-30

决定日期2025-12-30

产品代码FLE

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

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Lucas Lifecare. It received FDA 510(k) clearance on 2025-12-30 under 510(k) number K250168. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a medical device that received FDA 510(k) clearance on 2025-12-30. The listed applicant is Lucas Lifecare. The 510(k) number is K250168.

When did Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer receive FDA 510(k) clearance?

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer received FDA 510(k) clearance on 2025-12-30, under 510(k) number K250168.

Who is the listed applicant for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?

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

What is the FDA product code for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?

The FDA product code for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is FLE.

列明Lucas Lifecare为申报人的其他记录

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