FDA 510(k)

ヘリオス+ UV-C システム

K番号: K242604 · 2025-05-27

申請者Preventamed Technologies, Inc. Dba Surfacide Manufacturing

決定日2025-05-27

製品コードQXJ

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Helios+ UV-C System is the device name listed in this FDA 510(k) record. The listed applicant is Preventamed Technologies, Inc. Dba Surfacide Manufacturing. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K242604. The device is classified under product code QXJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Helios+ UV-C System?

Helios+ UV-C System is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Preventamed Technologies, Inc. Dba Surfacide Manufacturing. The 510(k) number is K242604.

When did Helios+ UV-C System receive FDA 510(k) clearance?

Helios+ UV-C System received FDA 510(k) clearance on 2025-05-27, under 510(k) number K242604.

Who is the listed applicant for Helios+ UV-C System?

The FDA 510(k) record lists Preventamed Technologies, Inc. Dba Surfacide Manufacturing as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Helios+ UV-C System?

The FDA product code for Helios+ UV-C System is QXJ.

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医療機器の概要

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