K-number	K897116
Device name	OPTIMA MPT MODEL 5281E AND MODEL 5282E
Applicant	Telectronics Pacing Systems, Inc.
Product code	DXY
Device class	Class III
Decision date	Mar 14, 1990
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 →

OPTIMA MPT MODEL 5281E AND MODEL 5282E

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