LIFESTYLE OXYGEN CONCENTRATOR
FDA 510(k) clearance K020324 · decided 2002-03-13
Clearance details
- K-number
- K020324
- Device name
- LIFESTYLE OXYGEN CONCENTRATOR
- Applicant
- Airsep Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-31
- Decision date
- 2002-03-13
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. recall (Z-0478-2025) | Caire, Inc. | 2024-11-15 |
| CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. recall (Z-0479-2025) | Caire, Inc. | 2024-11-15 |
| Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded recall (Z-0768-2013) | Oxus America, Inc. | 2013-02-02 |