FDA 510(k)

图腾纳预真空蒸汽灭菌器型号3870HSG和3870HSG-WS

K号: K222608 · 2022-12-16

决定日期2022-12-16

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

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is the device name listed in this FDA 510(k) record. The listed applicant is Tuttnauer , Ltd.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222608. 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 Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Tuttnauer , Ltd.. The 510(k) number is K222608.

When did Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS receive FDA 510(k) clearance?

Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS received FDA 510(k) clearance on 2022-12-16, under 510(k) number K222608.

Who is the listed applicant for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

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

What is the FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS?

The FDA product code for Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS is FLE.

列明Tuttnauer , Ltd.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。

K221227Tuttnauer 水平式高压蒸汽灭菌器系列型号：4472，5596，6690，66120 K213080T-Edge 10, T-Edge 11 K181456Tuttnauer水平模型：4472、5596、6690、66120、69120和69180高压灭菌器

官方来源

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