FDA 510(k)

Medical Face Mask

K番号: K212471 · 2021-11-04

決定日2021-11-04

製品コードFXX

諮問委員会SU

決定Substantially Equivalent

医療機器の概要

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Haian Medigauze Co., Ltd.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212471. 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 Medical Face Mask?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Haian Medigauze Co., Ltd.. The 510(k) number is K212471.

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

Medical Face Mask received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212471.

Who is the listed applicant for Medical Face Mask?

The FDA 510(k) record lists Haian Medigauze Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

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Medical Face Mask

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