IntelAir Nasal Airway Support System— 510(k) K142467
Substantially EquivalentAbeon Medical Corporation
FDA 510(k) clearance K142467 for IntelAir Nasal Airway Support System, Substantially Equivalent on 2014-11-24. Applicant: Abeon Medical Corporation.
Clearance details
- Applicant
- Abeon Medical Corporation
- Product code
- Code CCK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brecksville, OH, US
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.