Device |
monitor for opioid induced impairment of oxygenation |
Definition |
A monitor for opioid induced impairment of oxygenation is a device that uses sensor hardware and software algorithms to detect desaturations of arterial oxygen saturation resulting from opioid overdose |
Physical State |
Software/algorithm |
Technical Method |
Analyzes physiologic sensor data to detect opioid induced impairment of oxygenation |
Target Area |
Peripheral circulatory pulse |
Regulation Medical Specialty |
Anesthesiology |
Review Panel |
Anesthesiology |
Product Code | QVT |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
Submission Type |
510(k)
|
Regulation Number |
868.2250
|
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 |