FDA 510(k)

Savvyマスク - レベル3手術用マスク

K番号: K213406 · 2021-11-18

決定日2021-11-18

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 Mask - Level 3 Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Texas Medplast, LLC. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213406. 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 Mask - Level 3 Surgical Face Mask?

Savvy Mask - Level 3 Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Texas Medplast, LLC. The 510(k) number is K213406.

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

Savvy Mask - Level 3 Surgical Face Mask received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213406.

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

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

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

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

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Savvyマスク - レベル3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