QWEClass II
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Anesthesiology · 21 CFR 870.2720
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.
MDR events2All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances1All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Malfunction2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code