QOA — Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening Class N
FDA product code QOA covers "Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QOA
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
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