K-number	K000842
Device name	CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
Applicant	Sims Deltec, Inc.
Product code	FRN
Device class	Class II
Decision date	Jun 8, 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 →

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 →

CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM

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