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 Nebulizer (Direct Patient Interface)
510(k) Number K935693
Device Name AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J STREET, SUITE 354
SACRAMENTO,  CA  95819
Applicant Contact GORDON A WONG, M.D.
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
3941 J STREET, SUITE 354
SACRAMENTO,  CA  95819
Correspondent Contact GORDON A WONG, M.D.
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/29/1993
Decision Date 08/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-