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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State Algorithm/Software
Technical Method Analysis of signals from a blood pressure cuff on the upper arm or wrist to determine the presence of Atrial Fibrillation.
Target Area Upper or Lower Extremity and Heart
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQXY
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.1135
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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