Name: Predicase
Price: 199 USD

K-number	K183646
Device name	Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure
Applicant	Edwards Lifeciences, LLC
Product code	QAQ
Device class	Class II
Decision date	May 21, 2019
Decision	Substantially Equivalent
Regulation	870.2210

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 →

Acumen Hypotension Prediction Index  EV1000 Clinical Platform, Acumen Hypotension Prediction Index  HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index  HemoSphere Advanced Monitoring Platform - Pressure

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

Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure