FDA 510(k)

プロサンサンランプ製品、ルクシーラサンランプ製品

K番号: K181455 · 2018-09-10

決定日2018-09-10

製品コードLEJ

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

ProSun sunlamp products, Luxura sunlamp products is the device name listed in this FDA 510(k) record. The listed applicant is Prosun International, LLC. It received FDA 510(k) clearance on 2018-09-10 under 510(k) number K181455. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the ProSun sunlamp products, Luxura sunlamp products?

ProSun sunlamp products, Luxura sunlamp products is a medical device that received FDA 510(k) clearance on 2018-09-10. The listed applicant is Prosun International, LLC. The 510(k) number is K181455.

When did ProSun sunlamp products, Luxura sunlamp products receive FDA 510(k) clearance?

ProSun sunlamp products, Luxura sunlamp products received FDA 510(k) clearance on 2018-09-10, under 510(k) number K181455.

Who is the listed applicant for ProSun sunlamp products, Luxura sunlamp products?

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

What is the FDA product code for ProSun sunlamp products, Luxura sunlamp products?

The FDA product code for ProSun sunlamp products, Luxura sunlamp products is LEJ.

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プロサンサンランプ製品、ルクシーラサンランプ製品

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：LEJ）

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