FDA 510(k)

PRO-DOSE系統

K 號：K250083 · 2025-10-01

決定日期2025-10-01

產品代碼NZT

諮詢委員會RA

決定相當於

器材摘要

PRO-DOSE System is the device name listed in this FDA 510(k) record. The listed applicant is Nu-Rise, SA. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K250083. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PRO-DOSE System?

PRO-DOSE System is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is Nu-Rise, SA. The 510(k) number is K250083.

When did PRO-DOSE System receive FDA 510(k) clearance?

PRO-DOSE System received FDA 510(k) clearance on 2025-10-01, under 510(k) number K250083.

Who is the listed applicant for PRO-DOSE System?

The FDA 510(k) record lists Nu-Rise, SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-DOSE System?

The FDA product code for PRO-DOSE System is NZT.

相關器械（代碼：NZT）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：NZT）

官方來源