1 device · 1 company · 2021
Product code QOK: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
1 device under product code QOK, 2021, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate. 21 CFR 870.2786, Class II. The device uses an optical sensor system and software algorithms to obtain and analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Gili Pro BioSensorDEN200038 · De Novo | ContinUse Biometrics Ltd. | Cardiovascular | database entry |
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