Global Hypoperfusion Index (GHI) Algorithm— 510(k) K231038

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K231038 for Global Hypoperfusion Index (GHI) Algorithm, Substantially Equivalent on 2023-07-26. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code QNL
Advisory panel: Cardiovascular
Date received: 2023-04-12
Decision date: 2023-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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