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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device atrial fibrillation risk prediction machine learning-based notification software
Definition Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up.
Product CodeSBQ
Regulation Number 870.2380
Device Class 2


Premarket Reviews
ManufacturerDecision
TEMPUS AI, INC.
  SUBSTANTIALLY EQUIVALENT 1

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