FDA 510(k)

VHT-200 點膚治療系統

K 號：K212121 · 2023-03-23

決定日期2023-03-23

產品代碼KPJ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

VHT-200 Wound Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Vaporox, Inc.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K212121. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VHT-200 Wound Treatment System?

VHT-200 Wound Treatment System is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Vaporox, Inc.. The 510(k) number is K212121.

When did VHT-200 Wound Treatment System receive FDA 510(k) clearance?

VHT-200 Wound Treatment System received FDA 510(k) clearance on 2023-03-23, under 510(k) number K212121.

Who is the listed applicant for VHT-200 Wound Treatment System?

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

What is the FDA product code for VHT-200 Wound Treatment System?

The FDA product code for VHT-200 Wound Treatment System is KPJ.

其他以 Vaporox, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250188傷口治療系統（VHT-200）

相關器械（代碼：KPJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250188傷口治療系統（VHT-200）Vaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba Ogenix

官方來源

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