Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure— 510(k) K183646
Substantially EquivalentEdwards Lifeciences, LLC
FDA 510(k) clearance K183646 for Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure, Substantially Equivalent on 2019-05-21. Applicant: Edwards Lifeciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifeciences, LLC
- Product code
- Code QAQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code QAQ
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