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FDA 510(k)

VHT-200 创面治疗系统

K号: K212121 · 2023-03-23

申请人Vaporox, Inc.
决定日期2023-03-23
产品代码KPJ
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

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.

常见问题

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.

相关临床试验

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列明Vaporox, Inc.为申报人的其他记录

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相关器械(代码:KPJ)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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