510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QOANot classified

Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening

Unknown
FDA source (opens on fda.gov)

QOA is the FDA product code for Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QOA
Device name
Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening
FDA 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
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QOA.