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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oscillometric-based, over-the-counter, atrial fibrillation notification feature
Definition An oscillometric-based, over-the-counter, atrial fibrillation notification feature is a software algorithm for analysis of signals from an oscillometric, non-invasive blood pressure measurement system to screen for possible atrial fibrillation in the device user.
Product CodeQXY
Regulation Number 870.1135
Device Class 2


Premarket Reviews
ManufacturerDecision
OMRON HEALTHCARE, INC.
  GRANTED 1

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