Global Hypoperfusion Index (GHI) Algorithm
FDA 510(k) K231038 · Edwards Lifesciences, LLC
Submission
- Device name
- Global Hypoperfusion Index (GHI) Algorithm
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- April 12, 2023
- Decision date
- July 26, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNL – Medium-Term Adjunctive Predictive Cardiovascular Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2210
- Specialty
- Cardiovascular
The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events within a defined medium-term period. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
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| K200717 | CLEWICU System (ClewICUServer and ClewICUnitor)QNL · Traditional | Clew Medical , Ltd. | 01/09/2021SE |
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Questions and answers
When was Global Hypoperfusion Index (GHI) Algorithm cleared by the FDA?
Global Hypoperfusion Index (GHI) Algorithm (K231038) received a 510(k) decision of Substantially Equivalent on July 26, 2023, 105 days after the submission was received.
What is the product code of K231038?
The FDA product code is QNL – Medium-Term Adjunctive Predictive Cardiovascular Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2210.