510(k) K142467

IntelAir Nasal Airway Support System by Abeon Medical Corporation — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2014
Date Received
September 3, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type