FDA 510(k)

U Guard 耳掛けと留め具付きマスク（青、白または緑）

K番号: K153409 · 2016-11-15

決定日2016-11-15

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

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is the device name listed in this FDA 510(k) record. The listed applicant is Protect U Guard, LLC. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K153409. 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 Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Protect U Guard, LLC. The 510(k) number is K153409.

When did Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) receive FDA 510(k) clearance?

Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) received FDA 510(k) clearance on 2016-11-15, under 510(k) number K153409.

Who is the listed applicant for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

The FDA 510(k) record lists Protect U Guard, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)?

The FDA product code for Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) is FXX.

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U Guard 耳掛けと留め具付きマスク（青、白または緑）

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