Product code QOA
- Device name
- Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
- Medical specialty
- Unknown
- Device class
- N
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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
- Source
- FDA openFDA device classification dataset