Cardiology
Analytic for Hemodynamic Instability (AHI)
Fifth Eye Inc.
FDA-cleared AI medical device
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information.
FDA Submission Metadata
- Submission number
- DEN200022
- Decision date
- March 2021
- FDA panel
- Cardiovascular
- Product code
- QNV
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
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