Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform— 510(k) K203224
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K203224 for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform, Substantially Equivalent on 2021-07-30. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, 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
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More clearances from Edwards Lifesciences, LLC
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