FDA 510(k)

手術用マスク（GFM 96、GFM 91、GFM 90、GFM 88、GFM 81、GFM 80）

K番号: K222266 · 2022-09-26

申請者Jingzhou Haixin Green Cross Medical Products Co., Ltd.

決定日2022-09-26

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

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is the device name listed in this FDA 510(k) record. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K222266. 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 Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The 510(k) number is K222266.

When did Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) receive FDA 510(k) clearance?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) received FDA 510(k) clearance on 2022-09-26, under 510(k) number K222266.

Who is the listed applicant for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

The FDA 510(k) record lists Jingzhou Haixin Green Cross Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

The FDA product code for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is FXX.

申請者としてJingzhou Haixin Green Cross Medical Products Co., Ltd.を記載するその他の記録

K171535手術隔離衣

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