FDA 510(k)

ICUヘルス手術マスク

K番号: K203064 · 2021-03-23

決定日2021-03-23

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

ICU Health Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Plastikon Industries. It received FDA 510(k) clearance on 2021-03-23 under 510(k) number K203064. 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 ICU Health Surgical Mask?

ICU Health Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-03-23. The listed applicant is Plastikon Industries. The 510(k) number is K203064.

When did ICU Health Surgical Mask receive FDA 510(k) clearance?

ICU Health Surgical Mask received FDA 510(k) clearance on 2021-03-23, under 510(k) number K203064.

Who is the listed applicant for ICU Health Surgical Mask?

The FDA 510(k) record lists Plastikon Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICU Health Surgical Mask?

The FDA product code for ICU Health Surgical Mask is FXX.

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ICUヘルス手術マスク

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