Name: Predicase
Price: 199 USD

K-number	K120333
Device name	PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
Applicant	Gambro Renal Products
Product code	KPO
Device class	Class II
Decision date	May 25, 2012
Decision	Substantially Equivalent
Regulation	876.5820

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 →

PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

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