FDA 510(k)

Secure Wear USA 手術用マスク

K番号: K203101 · 2021-03-31

申請者Secured Ortho Manufacturing of America, LLC

決定日2021-03-31

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

Secure Wear USA Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Secured Ortho Manufacturing of America, LLC. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K203101. 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 Secure Wear USA Surgical Face Mask?

Secure Wear USA Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Secured Ortho Manufacturing of America, LLC. The 510(k) number is K203101.

When did Secure Wear USA Surgical Face Mask receive FDA 510(k) clearance?

Secure Wear USA Surgical Face Mask received FDA 510(k) clearance on 2021-03-31, under 510(k) number K203101.

Who is the listed applicant for Secure Wear USA Surgical Face Mask?

The FDA 510(k) record lists Secured Ortho Manufacturing of America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Secure Wear USA Surgical Face Mask?

The FDA product code for Secure Wear USA Surgical Face Mask is FXX.

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Secure Wear USA 手術用マスク

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）

公式ソース