GCE Zen-O Portable Oxygen Concentrator— 510(k) K162433
Substantially EquivalentOxus, Inc.
FDA 510(k) clearance K162433 for GCE Zen-O Portable Oxygen Concentrator, Substantially Equivalent on 2017-05-24. Applicant: Oxus, Inc.. Device class: 2.
Clearance details
- Applicant
- Oxus, Inc.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auburn Hills, MI, US
Recent devices under product code CAW
view allMore clearances from Oxus, Inc.
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162433
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162433.
Data sourced from openFDA. This site is unofficial and independent of the FDA.