FDA 510(k)

プルアビタメディカルフラット手術用マスク

K番号: K212740 · 2021-12-02

決定日2021-12-02

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

Puravita Medical Fold Flat Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Puravita M, LLC. It received FDA 510(k) clearance on 2021-12-02 under 510(k) number K212740. 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 Puravita Medical Fold Flat Surgical Mask?

Puravita Medical Fold Flat Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-12-02. The listed applicant is Puravita M, LLC. The 510(k) number is K212740.

When did Puravita Medical Fold Flat Surgical Mask receive FDA 510(k) clearance?

Puravita Medical Fold Flat Surgical Mask received FDA 510(k) clearance on 2021-12-02, under 510(k) number K212740.

Who is the listed applicant for Puravita Medical Fold Flat Surgical Mask?

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

What is the FDA product code for Puravita Medical Fold Flat Surgical Mask?

The FDA product code for Puravita Medical Fold Flat Surgical Mask is FXX.

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プルアビタメディカルフラット手術用マスク

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