# Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
> **Product code: QOK** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2786
## Classification
- **FDA Product Code:** QOK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.2786
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QOK)
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