Oxysure Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
1
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2253-2015Class IIOxySure Model 615 disposable replacement cartridges, for portable oxygen generator.June 12, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K052396OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615December 9, 2005