Medevac Use Oxygen Generator
The MEDEVAC Use Oxygen Generator (product code OLF) is a Class 2 device regulated under 21 CFR 868.5440 in the Anesthesiology specialty (AN), cleared through the 510(k) pathway. It is intended to release oxygen for respiratory therapy, using either a chemical reaction or physical means such as a molecular sieve, and is designed exclusively for use aboard MEDEVAC helicopters where it is affixed to the aircraft. The device carries a life-sustaining or life-supporting flag, reflecting its critical role in patient care during aeromedical evacuation.
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Basic Information
- Product Code
- OLF
- Device Class
- FDA class 2
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082829 | AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) | Dec 22, 2008 | Substantially Equivalent | Carleton Life Support Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.