Product Classification

• Device: ppg sensor wearable for hypercoagulation detection and covid-19 screening
• Definition: PPG sensor wearable device used in conjunction with thermometers to triage asymptomatic individuals for COVID-19 risk in settings where thermometers are being used for such purpose in accordance with CDC and institutional infection prevention and control guidelines
• Physical State: n/a
• Technical Method: n/a
• Target Area: n/a
• Review Panel: Cardiovascular
• Product Code: QOA
• Premarket Review: Office of Cardiovascular Devices (OHT2); Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
• Not Classified Reason: EUA - Emergency Use Authorization
• Submission Type: EUA - Emergency Use Authorization
• Device Class: Not Classified
• 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