FDA 510(k)

デュリオ外科フェイスマスク、モデル501（3重、青）および545（4重、青）

K番号: K230395 · 2023-07-17

決定日2023-07-17

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

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is the device name listed in this FDA 510(k) record. The listed applicant is Durio Ppe Sdn Bhd. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230395. 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 Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Durio Ppe Sdn Bhd. The 510(k) number is K230395.

When did Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) receive FDA 510(k) clearance?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230395.

Who is the listed applicant for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

The FDA 510(k) record lists Durio Ppe Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

The FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is FXX.

公式ソース

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デュリオ外科フェイスマスク、モデル501（3重、青）および545（4重、青）

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