FDA 510(k)

3M 高性能手術マスク、3M 高性能手術マスクフェイスシールド付き

K番号: K180874 · 2018-07-31

決定日2018-07-31

製品コードFXX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2018-07-31 under 510(k) number K180874. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is a medical device that received FDA 510(k) clearance on 2018-07-31. The listed applicant is 3M Healthcare. The 510(k) number is K180874.

When did 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield receive FDA 510(k) clearance?

3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield received FDA 510(k) clearance on 2018-07-31, under 510(k) number K180874.

Who is the listed applicant for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

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 High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield?

The FDA product code for 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield is FXX.

申請者として3M Healthcareを記載するその他の記録

K1931103M Attest 水素過酸素蒸発トリメトリック化学指示器 1348/1348E K1913553M™ ハイフルイドレジスタント手術用マスクおよび 3M™ ハイフルイドレジスタントプロセスマスク K1804043M Clarity ウルトラ自己留め括り具および接着コートアプライアンスシステム K1711163M™ VFlex™ 医療用粒子呼吸器および手術用マスク、モデル 1804/1804S K153571Cavilon アドバンスドハイエンドユアリングスキンプロテクタント

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