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Reduced Ejection Fraction Machine Learning-Based Notification Software

FDA product code QYE · 5 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2380
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2023-09-28 – 2025-09-19

Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.

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