FDA 510(k)

流体抵抗性手術マスク、流体抵抗性プロシージャーマスク

K番号: K211832 · 2021-09-08

申請者Zhejiang Lanhine Medical Products, Ltd.

決定日2021-09-08

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

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K211832. 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 Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Zhejiang Lanhine Medical Products, Ltd.. The 510(k) number is K211832.

When did Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask receive FDA 510(k) clearance?

Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask received FDA 510(k) clearance on 2021-09-08, under 510(k) number K211832.

Who is the listed applicant for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA 510(k) record lists Zhejiang Lanhine Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask?

The FDA product code for Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask is FXX.

申請者としてZhejiang Lanhine Medical Products, Ltd.を記載するその他の記録

K211827レベル3 液漏防止手術マスク（モデル：15604F、1570F）

公式ソース

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