Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K142467
Device Name IntelAir Nasal Airway Support System
Applicant
Abeon Medical Corporation
8000 Katherine Blvd.
Brecksville,  OH  44141
Applicant Contact ALLISON SLAGA
Correspondent
Abeon Medical Corporation
8000 Katherine Blvd.
Brecksville,  OH  44141
Correspondent Contact ALLISON SLAGA
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/03/2014
Decision Date 11/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-