Name: Predicase
Price: 199 USD

K-number	K994331
Device name	REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
Applicant	Medtronic Vascular
Product code	MXC
Device class	Class II
Decision date	Jan 21, 2000
Decision	Substantially Equivalent
Regulation	870.2800

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 →

REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR

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