Name: Predicase
Price: 199 USD

K-number	K093902
Device name	MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
Applicant	Fresenius Medical Care North America
Product code	KDI
Device class	Class II
Decision date	May 27, 2010
Decision	Substantially Equivalent
Regulation	876.5860

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573

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