Oxysure Systems, Inc.
Medical device manufacturer in Frisco, TX.
1510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K052396 | Oxysure Portable Oxygen Generator, Model 615CAW · Traditional | 12/09/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2253-2015 Class II | OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.Flow rate of the recalled replacement cartridges does not meet the draft FDA standard of a minimum 6 LPM for… | 06/12/2015Terminated |