FDA product code QOA: Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
QOA is the FDA product code for ppg sensor wearable for hypercoagulation detection and covid-19 screening. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QOA reach the market by PMA; FDA lists no cleared 510(k)s for it.
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
Classification
| Field | Value |
|---|---|
| Device name | Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QOA devices
openFDA lists no recalls for product code QOA.
Frequently asked questions
What is FDA product code QOA?
QOA is the FDA product code for ppg sensor wearable for hypercoagulation detection and covid-19 screening. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QOA?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QOA
- Run a recall and safety report across every QOA manufacturer
- Watch product code QOA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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