Drive Solstice Oxygen Concentrator
by Medical Depot 510(k)
Active
510(k) K080391
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080391 | Date18 Mar 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0407-2018
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
Specification
- 510(k) Number
- FDA Product Code
- CAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5440
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent