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Ppg Sensor Wearable For Hypercoagulation Detection And Covid-19 Screening

QOA · Not classified · Unknown

Classification

FDA Product Code
QOA
Device class
Not classified
Regulation
Review panel
CV
Medical specialty
Unknown
Submission type
8
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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