Acumen Hypotension Prediction Index (HPI) Feature Software— 510(k) DEN160044
UnknownEdwards Lifesciences, LLC
FDA 510(k) clearance DEN160044 for Acumen Hypotension Prediction Index (HPI) Feature Software, Unknown on 2018-03-16. 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
- Unknown
- Clearance type
- Direct
- Location
- Irvine, CA, US
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