FDA 510(k)

トプワイド手術用フェイスマスク

K番号: K210102 · 2021-12-17

申請者Topwide (Hubei) Medical Products Manufacturer

決定日2021-12-17

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

Topwide Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Topwide (Hubei) Medical Products Manufacturer. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K210102. 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 Topwide Surgical Face Mask?

Topwide Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Topwide (Hubei) Medical Products Manufacturer. The 510(k) number is K210102.

When did Topwide Surgical Face Mask receive FDA 510(k) clearance?

Topwide Surgical Face Mask received FDA 510(k) clearance on 2021-12-17, under 510(k) number K210102.

Who is the listed applicant for Topwide Surgical Face Mask?

The FDA 510(k) record lists Topwide (Hubei) Medical Products Manufacturer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Topwide Surgical Face Mask?

The FDA product code for Topwide Surgical Face Mask is FXX.

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トプワイド手術用フェイスマスク

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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