INOGEN ONE OXYGEN CONCENTRATOR
FDA 510(k) clearance K032818 · decided 2004-05-13
Clearance details
- K-number
- K032818
- Device name
- INOGEN ONE OXYGEN CONCENTRATOR
- Applicant
- Inogen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-10
- Decision date
- 2004-05-13
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Goleta, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Portable Oxygen Generator recall (Z-1368-05) | Inogen, Inc | 2005-08-12 |