FDA 510(k)

ViVY

K 號：K250376 · 2025-11-05

決定日期2025-11-05

產品代碼IMJ

諮詢委員會PM

決定相當於

器材摘要

ViVY is the device name listed in this FDA 510(k) record. The listed applicant is Viatherm Therapeutics, LLC. It received FDA 510(k) clearance on 2025-11-05 under 510(k) number K250376. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ViVY?

ViVY is a medical device that received FDA 510(k) clearance on 2025-11-05. The listed applicant is Viatherm Therapeutics, LLC. The 510(k) number is K250376.

When did ViVY receive FDA 510(k) clearance?

ViVY received FDA 510(k) clearance on 2025-11-05, under 510(k) number K250376.

Who is the listed applicant for ViVY?

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

What is the FDA product code for ViVY?

The FDA product code for ViVY is IMJ.

其他以 Viatherm Therapeutics, LLC 為申請人之記錄

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K173300通熱加強器

相關器械（代碼：IMJ）

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。

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官方來源

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