K-number	K882427
Device name	CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
Applicant	Ela Medical, Inc.
Product code	DXY
Device class	Class III
Decision date	Sep 23, 1988
Decision	Substantially Equivalent
Regulation	870.3610

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 →

CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066

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