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FDA 510(k)

PRO-DOSE System

K-Number: K250083 · 2025-10-01

ApplicantNu-Rise, SA
Decision Date2025-10-01
Product CodeNZT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the PRO-DOSE System?

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

When was PRO-DOSE System approved by the FDA?

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

What company makes PRO-DOSE System?

PRO-DOSE System is manufactured by Nu-Rise, SA.

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

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

Related Devices (Code: NZT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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