FDA 510(k)

3M Curos タンパー証明デバイス、3M Curos タンパー証明デバイス、ラージ

K番号: K220507 · 2022-05-23

決定日2022-05-23

製品コードPZW

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 Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2022-05-23 under 510(k) number K220507. The device is classified under product code PZW. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large?

3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is 3M Company. The 510(k) number is K220507.

When did 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large receive FDA 510(k) clearance?

3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large received FDA 510(k) clearance on 2022-05-23, under 510(k) number K220507.

Who is the listed applicant for 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large?

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 Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large?

The FDA product code for 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large is PZW.

申請者として3M Companyを記載するその他の記録

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