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U.S. Department of Health and Human Services

Product Classification

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Device photoplethysmograph analysis software for over-the-counter use
Definition A photoplethysmograph analysis software device for over-the-counter use analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.
Physical State Software.
Technical Method Analyzes photoplethysmograph data and provides detection information.
Target Area Software.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeQDB
Premarket Review Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 870.2790
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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