Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
FDA 510(k) clearance K172648 · decided 2018-03-23
Clearance details
- K-number
- K172648
- Device name
- Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
- Applicant
- Devilbiss Healthcare, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-09-01
- Decision date
- 2018-03-23
- Days to decision
- 203 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemen recall (Z-0229-2023) | DeVilbiss Healthcare LLC | 2022-11-11 |