FDA 510(k)

3M™ アッテスト™ ラピッドリードアウトバイオロジカルインディケーター 1295および3M™ アッテスト™ 水素酸素蒸気トリメトリック化学的指標 1348/1348E

K番号: K240717 · 2024-06-27

決定日2024-06-27

製品コードFRC

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™ Rapid Readout Biological Indicator 1295 and 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 2024-06-27 under 510(k) number K240717. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is 3M Company. The 510(k) number is K240717.

When did 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E receive FDA 510(k) clearance?

3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E received FDA 510(k) clearance on 2024-06-27, under 510(k) number K240717.

Who is the listed applicant for 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 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™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

The FDA product code for 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is FRC.

申請者として3M Companyを記載するその他の記録

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