FDA 510(k) Premarket Notification K142467: IntelAir Nasal Airway Support System

Submission Details & Decision

Normalized public record details for 510(k) notification K142467.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K142467

Applicant / Sponsor

Abeon Medical Corporation

Device Name

IntelAir Nasal Airway Support System

Product Code

CCK

Decision Date

2014-11-24

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Anesthesiology (AN)

Clearance Type

Special

Third Party Flag

Date Received

2014-09-03

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