Name: Predicase
Price: 199 USD

K-number	K082308
Device name	MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
Applicant	Edwards Lifesciences, LLC
Product code	DXG
Device class	Class II
Decision date	Dec 9, 2008
Decision	Substantially Equivalent
Regulation	870.1435

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 →

MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR

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