Name: Predicase
Price: 199 USD

K-number	K002211
Device name	COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151
Applicant	Baxter Healthcare Corp
Product code	FRN
Device class	Class II
Decision date	Jul 28, 2000
Decision	Substantially Equivalent
Regulation	880.5725

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 →

COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151

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