FDA 510(k)

D-Care手術用マスク3重、D-Care医療用マスク3重

K番号: K213970 · 2022-01-23

申請者Danameco Medical Joint Stock Corporation

決定日2022-01-23

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

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is the device name listed in this FDA 510(k) record. The listed applicant is Danameco Medical Joint Stock Corporation. It received FDA 510(k) clearance on 2022-01-23 under 510(k) number K213970. 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 D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is a medical device that received FDA 510(k) clearance on 2022-01-23. The listed applicant is Danameco Medical Joint Stock Corporation. The 510(k) number is K213970.

When did D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply receive FDA 510(k) clearance?

D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply received FDA 510(k) clearance on 2022-01-23, under 510(k) number K213970.

Who is the listed applicant for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA 510(k) record lists Danameco Medical Joint Stock Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply?

The FDA product code for D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply is FXX.

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D-Care手術用マスク3重、D-Care医療用マスク3重

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