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U.S. Department of Health and Human Services

Product Classification
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Device loss of pulse notification software
Regulation Description 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 loss of pulse. 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 CodeSDY
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
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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