Invacare Platinum 5NXG Oxygen Concentrator— 510(k) K203210
Substantially EquivalentInvacare Corporation
FDA 510(k) clearance K203210 for Invacare Platinum 5NXG Oxygen Concentrator, Substantially Equivalent on 2021-04-12. Applicant: Invacare Corporation. Device class: 2.
Clearance details
- Applicant
- Invacare Corporation
- 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
- Elyria, OH, US
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Adverse 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 K203210
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 K203210.
Data sourced from openFDA. This site is unofficial and independent of the FDA.