Name: Predicase
Price: 199 USD

K-number	K992275
Device name	FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
Applicant	Fresenius USA, Inc.
Product code	KDI
Device class	Class II
Decision date	Aug 4, 1999
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 →

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS

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