K-number	K933818
Device name	GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER
Applicant	C.G.H. Medical, Inc.
Product code	KDI
Device class	Class II
Decision date	Jan 25, 1995
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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER

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