AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
FDA 510(k) clearance K082829 · decided 2008-12-22
Clearance details
- K-number
- K082829
- Device name
- AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
- Applicant
- Carleton Life Support Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-25
- Decision date
- 2008-12-22
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- OLF
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Davenport, IA, US
- Third-party review
- No
- Expedited review
- Yes
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxy recall (Z-2009-2009) | Carleton Life Support Systems Inc | 2009-09-16 |