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
| Device Type ID | 193 |
| Device Name | Medevac Use Oxygen Generator |
| 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 CA |
| 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 Description | Portable Oxygen Generator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OLF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 193 |
| Device | Medevac Use Oxygen Generator |
| Product Code | OLF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Portable Oxygen Generator. |
| CFR Regulation Number | 868.5440 [🔎] |