FDA 510(k)

Mojo 全顔通気マスク；Veraseal 2 全顔通気マスク；Innova 全顔通気マスク；Ascend 全顔通気マスク

K番号: K241830 · 2024-10-18

決定日2024-10-18

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

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2024-10-18 under 510(k) number K241830. 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 Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask?

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask is a medical device that received FDA 510(k) clearance on 2024-10-18. The listed applicant is Sleepnet Corporation. The 510(k) number is K241830.

When did Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask receive FDA 510(k) clearance?

Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask received FDA 510(k) clearance on 2024-10-18, under 510(k) number K241830.

Who is the listed applicant for Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask?

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

What is the FDA product code for Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask?

The FDA product code for Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask is BZD.