FDA 510(k)

3M Attest 蒸汽过氧化氢三计量化学指示剂 1348/1348E

K号: K193110 · 2020-03-13

决定日期2020-03-13

产品代码QKM

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

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193110. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is 3M Healthcare. The 510(k) number is K193110.

When did 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E receive FDA 510(k) clearance?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193110.

Who is the listed applicant for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

The FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is QKM.

列明3M Healthcare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。

K1913553M® High Fluid-Resistant Surgical Mask and 3M® High Fluid-Resistant Procedure Mask K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield K1804043M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System K1711163M® VFlex® Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S K153571Cavilon 高级耐久皮肤保护剂

官方来源

在 FDA 数据库中查看 →

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。