Last synced on 19 July 2024 at 11:05 pm

Monitor For Opioid Induced Impairment Of Oxygenation

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2250
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QVT is linked to regulation 21CFR868.2250, which does not seem to exist yet. It may be pending at the moment.

Monitor For Opioid Induced Impairment Of Oxygenation

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.2250
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QVT is linked to regulation 21CFR868.2250, which does not seem to exist yet. It may be pending at the moment.