FDA 510(k)

WiZARD 520 Full Face Mask

K番号: K243023 · 2025-05-23

決定日2025-05-23

製品コードBZD

諮問委員会AN 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細情報や製品の詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

WiZARD 520 Full Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wellell, Inc.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K243023. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the WiZARD 520 Full Face Mask?

WiZARD 520 Full Face Mask is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Wellell, Inc.. The 510(k) number is K243023.

When did WiZARD 520 Full Face Mask receive FDA 510(k) clearance?

WiZARD 520 Full Face Mask received FDA 510(k) clearance on 2025-05-23, under 510(k) number K243023.

Who is the listed applicant for WiZARD 520 Full Face Mask?

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

What is the FDA product code for WiZARD 520 Full Face Mask?

The FDA product code for WiZARD 520 Full Face Mask is BZD.

申請者としてWellell, Inc.を記載するその他の記録

K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

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。