DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
FDA 510(k) clearance K071397 · decided 2007-10-01
Clearance details
- K-number
- K071397
- Device name
- DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
- Applicant
- Sunrise Medical
- Decision
- Substantially Equivalent
- Date received
- 2007-05-21
- Decision date
- 2007-10-01
- Days to decision
- 133 days
- Clearance type
- Special
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Somerset, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power cord recall (Z-1727-2025) | Medical Depot Inc. | 2025-05-09 |
| DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS recall (Z-1558-2023) | DeVilbiss Healthcare LLC | 2023-05-04 |
| DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q recall (Z-0724-2023) | DeVilbiss Healthcare LLC | 2022-12-19 |