Global Hypoperfusion Index (GHI) Algorithm— 510(k) K231038
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K231038 for Global Hypoperfusion Index (GHI) Algorithm, Substantially Equivalent on 2023-07-26. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code QNL
- 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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