FDA 510(k)

スマート手術マスク - レベル3

K番号: K230383 · 2023-03-06

決定日2023-03-06

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

Savvy Surgical Mask - Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Alg Health, LLC. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K230383. 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 Savvy Surgical Mask - Level 3?

Savvy Surgical Mask - Level 3 is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is Alg Health, LLC. The 510(k) number is K230383.

When did Savvy Surgical Mask - Level 3 receive FDA 510(k) clearance?

Savvy Surgical Mask - Level 3 received FDA 510(k) clearance on 2023-03-06, under 510(k) number K230383.

Who is the listed applicant for Savvy Surgical Mask - Level 3?

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

What is the FDA product code for Savvy Surgical Mask - Level 3?

The FDA product code for Savvy Surgical Mask - Level 3 is FXX.

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。

スマート手術マスク - レベル3

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：FXX）

公式ソース