FDA 510(k)

3M™ Attest™ 超快速蒸汽化过氧化氢清晰挑战包 1295PCD (1295PCD)

K号: K241542 · 2024-06-27

决定日期2024-06-27

产品代码FRC

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™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) 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 K241542. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)?

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) 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 K241542.

When did 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) receive FDA 510(k) clearance?

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) received FDA 510(k) clearance on 2024-06-27, under 510(k) number K241542.

Who is the listed applicant for 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)?

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™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)?

The FDA product code for 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) is FRC.

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