FDA product code QOK: Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
QOK is the FDA product code for hardware and software for optical camera-based measurement of heart rate and respiratory rate. It is a Class II device, regulated under 21 CFR 870.2786 and reviewed by the Cardiovascular panel. Devices under QOK reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate |
| Device class | Class II |
| Regulation | 21 CFR 870.2786 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QOK devices
openFDA lists no recalls for product code QOK.
Frequently asked questions
What is FDA product code QOK?
QOK is the FDA product code for hardware and software for optical camera-based measurement of heart rate and respiratory rate. It is a Class II device, regulated under 21 CFR 870.2786 and reviewed by the Cardiovascular panel.
What device class is QOK?
Class II, regulation 21 CFR 870.2786. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QOK
- Run a recall and safety report across every QOK manufacturer
- Watch product code QOK 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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