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 Generator, Oxygen, Portable
510(k) Number K052396
FOIA Releasable 510(k) K052396
Device Name OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
Applicant
OXYSURE SYSTEMS, INC.
2611 INTERNET BLVD., SUITE 109
FRISCO,  TX  75034
Applicant Contact JULIAN T ROSS
Correspondent
OXYSURE SYSTEMS, INC.
2611 INTERNET BLVD., SUITE 109
FRISCO,  TX  75034
Correspondent Contact JULIAN T ROSS
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/31/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-