K-number	K131525
Device name	SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
Applicant	Defibtech, LLC
Product code	MKJ
Device class	Class III
Decision date	Apr 24, 2014
Decision	Substantially Equivalent
Regulation	870.5310

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 →

SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES

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