FDA 510(k)

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

K番号: K202096 · 2021-02-02

決定日2021-02-02

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

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is the device name listed in this FDA 510(k) record. The listed applicant is Ecoguard, Inc.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K202096. 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 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Ecoguard, Inc.. The 510(k) number is K202096.

When did 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On receive FDA 510(k) clearance?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On received FDA 510(k) clearance on 2021-02-02, under 510(k) number K202096.

Who is the listed applicant for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

The FDA 510(k) record lists Ecoguard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

The FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is FXX.

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3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

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