FDA 510(k)

3M Attest 水素過酸素蒸発トリメトリック化学指示器 1348/1348E

K番号: K212022 · 2022-04-20

決定日2022-04-20

製品コードQKM

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

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 Company. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K212022. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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 2022-04-20. The listed applicant is 3M Company. The 510(k) number is K212022.

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 2022-04-20, under 510(k) number K212022.

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

The FDA 510(k) record lists 3M Company 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.

申請者として3M Companyを記載するその他の記録

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