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Index/Edwards Lifeciences, LLC
ALT-007073K183646Green Status

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

Edwards Lifeciences, LLC · Manufacturer

All identifiers (2)
Aletia (canonical)ALT-007073
FDA 510(k) · US (primary)K183646

Overview

Accountability Tier
Tier 2

Regulatory Registrations

🌐
US
FDA
ID: K183646
510k

Lifecycle Signals

Last Automated Sync
Jun 2026
Last Clinical Review
Not reviewed
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