| Device |
medevac use oxygen generator |
| Definition |
A MEDEVAC oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve) to be used exclusively aboard a MEDEVAC helicopter and affixed to the helicopter. For general use portable oxygen generators, use product code CAW. |
| Physical State |
oxygen concentrator, tubing, monitors and gauges, oxygen tank. This classification is only for oxygen generators that are used on MEDEVAC helicopters and are permanently affixed to the helicopter. For general use oxygen generators use product code CAW. |
| Technical Method |
This device uses a molecular sieve (for example zeolite) or other means to concentrate oxygen for medical use. For general use portable oxygen generators, use product code CAW. |
| Target Area |
This device is intended to provide oxygen for patients. |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | OLF |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.5440
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
