FDA 510(k)

フィジオフィット医療用外科マスク

K番号: K201868 · 2021-02-22

決定日2021-02-22

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

Phyziofit Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wellpower Sporting Goods Co., Ltd.. It received FDA 510(k) clearance on 2021-02-22 under 510(k) number K201868. 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 Phyziofit Medical Surgical Mask?

Phyziofit Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-02-22. The listed applicant is Wellpower Sporting Goods Co., Ltd.. The 510(k) number is K201868.

When did Phyziofit Medical Surgical Mask receive FDA 510(k) clearance?

Phyziofit Medical Surgical Mask received FDA 510(k) clearance on 2021-02-22, under 510(k) number K201868.

Who is the listed applicant for Phyziofit Medical Surgical Mask?

The FDA 510(k) record lists Wellpower Sporting Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phyziofit Medical Surgical Mask?

The FDA product code for Phyziofit Medical Surgical Mask is FXX.

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フィジオフィット医療用外科マスク

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）

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