Last synced on 19 July 2024 at 11:05 pm

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Page Type
Product Code
Definition
A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.
Physical State
Software
Technical Method
The device is additional feature on pulse oximeter that uses additional wavelengths to monitor elevated hemoglobin levels or hyperoxia
Target Area
Finger tip surface
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2720
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 QWE is linked to regulation 21CFR870.2720, which does not seem to exist yet. It may be pending at the moment.

Hyperoxia Monitoring Device Adjunct To Pulse Oximetry

Page Type
Product Code
Definition
A hyperoxia monitoring device adjunct to pulse oximetry is a device that monitors elevated hemoglobin oxygen saturation levels as an adjunct to arterial oxygen saturation monitoring.
Physical State
Software
Technical Method
The device is additional feature on pulse oximeter that uses additional wavelengths to monitor elevated hemoglobin levels or hyperoxia
Target Area
Finger tip surface
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2720
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 QWE is linked to regulation 21CFR870.2720, which does not seem to exist yet. It may be pending at the moment.