Oxysure Systems, Inc.
FDA Regulatory Profile
Oxysure Systems, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2253-2015, Class II) was initiated on June 12, 2015. Its most recent 510(k) clearance was granted on December 9, 2005.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2253-2015 | Class II | OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. | June 12, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K052396 | OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615 | December 9, 2005 |