Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device photoplethysmograph analysis software for over-the-counter use
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 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 Office of 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
-
-