Name: Predicase
Price: 199 USD

K-number	K250471
Device name	AquaC UNO H
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	FIP
Device class	Class II
Decision date	Nov 14, 2025
Decision	Substantially Equivalent
Regulation	876.5665

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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AquaC UNO H

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