K-number	K250083
Device name	PRO-DOSE System
Applicant	Nu-Rise, SA
Product code	NZT
Device class	Class II
Decision date	Oct 1, 2025
Decision	Substantially Equivalent
Regulation	892.5050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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PRO-DOSE System

Everything you need for a 510(k) submission. Nothing you don't.