510(k) K082829
K082829 is an FDA 510(k) premarket notification submitted by Carleton Life Support Systems, Inc. for the device "AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)". The FDA issued a decision of Substantially Equivalent on December 22, 2008. The device falls under product code OLF (Medevac Use Oxygen Generator), a Class II device regulated under 21 CFR 868.5440. Carleton Life Support Systems, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2008
- Date Received
- September 25, 2008
- Clearance Type
- Traditional
- Expedited Review
- Yes
- Third Party Review
- No
Device Classification
- Device Name
- Medevac Use Oxygen Generator
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type
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.