| Device |
hardware and software for optical camera-based measurement of heart rate and respiratory rate |
| Regulation Description |
Hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. |
| 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. |
| Physical State |
Optical system consisting of a sensing unit and a mobile unit |
| Technical Method |
Uses an image sensor to capture the back-reflected light pattern from an illuminated subject |
| Target Area |
Chest |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QOK |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2786
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
