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U.S. Department of Health and Human Services

Product Classification
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Device reduced ejection fraction machine learning-based notification software
Definition 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.
Physical State Consists of one or more non-invasive physiological inputs, a machine learning based for disease detection or classification, and an output on the presence, absence, or likelihood of reduced ejection fraction.
Technical Method non-invasive physiological measurement(s)
Target Area Cardiovascular
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQYE
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2380
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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