FDA 510(k)

医療保護マスク（モデル：8862、8862A、8862B、8862C、8862D、8862E）

K番号: K223068 · 2022-11-23

申請者Guangdong Golden Leaves Technology Development Co., Ltd.

決定日2022-11-23

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

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Golden Leaves Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K223068. 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 Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)?

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Guangdong Golden Leaves Technology Development Co., Ltd.. The 510(k) number is K223068.

When did Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) receive FDA 510(k) clearance?

Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) received FDA 510(k) clearance on 2022-11-23, under 510(k) number K223068.

Who is the listed applicant for Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)?

The FDA 510(k) record lists Guangdong Golden Leaves Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)?

The FDA product code for Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) is FXX.

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医療保護マスク（モデル：8862、8862A、8862B、8862C、8862D、8862E）

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