DeviceClearance

IntelAir Nasal Airway Support System— 510(k) K142467

Substantially Equivalent

Abeon Medical Corporation

FDA 510(k) clearance K142467 for IntelAir Nasal Airway Support System, Substantially Equivalent on 2014-11-24. Applicant: Abeon Medical Corporation. Device class: 2.

Clearance details

Applicant
Abeon Medical Corporation
Product code
Code CCK
Device class
Class 2
Regulation
21 CFR 868.1400
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Brecksville, OH, US
Download summary PDFView on FDA.gov ↗

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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.