FDA 510(k)

コンフォートガードマスク、レベル1、コンフォートガードマスク、レベル3

K番号: K210860 · 2022-04-07

決定日2022-04-07

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

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2022-04-07 under 510(k) number K210860. 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 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is a medical device that received FDA 510(k) clearance on 2022-04-07. The listed applicant is Gri-Alleset, Inc.. The 510(k) number is K210860.

When did Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 receive FDA 510(k) clearance?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 received FDA 510(k) clearance on 2022-04-07, under 510(k) number K210860.

Who is the listed applicant for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

The FDA 510(k) record lists Gri-Alleset, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

The FDA product code for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is FXX.

申請者としてGri-Alleset, Inc.を記載するその他の記録

K242664gentleheel® 成人切開装置 K220917gentleheel マイクロプレミー、gentleheel プレミー、gentleheel ニューボーン、gentleheel トダラー K210131ComfortGuard手術隔離衣

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。