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 Ventilator, Continuous, Facility Use
510(k) Number K024344
Device Name PNEUTON VENTILATOR
Applicant
Airon Corporation
102 E. New Haven Ave. #146
Melbourne,  FL  32901
Applicant Contact G. ERIC GJERDE
Correspondent
Airon Corporation
102 E. New Haven Ave. #146
Melbourne,  FL  32901
Correspondent Contact G. ERIC GJERDE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received12/27/2002
Decision Date 06/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-