Name: Predicase
Price: 199 USD

K-number	K250634
Device name	BCM2-Body Composition Monitor
Applicant	Fresenius Medical Care Renal Therapies Group, LLC
Product code	DSB
Device class	Class II
Decision date	Nov 24, 2025
Decision	Substantially Equivalent
Regulation	870.2770

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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BCM2-Body Composition Monitor

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