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 K080082
Device Name OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS
Applicant
OXLIFE LLC
141 TWIN SPRINGS RD.
HENDERSONVILLE,  NC  28792
Applicant Contact MARGARET K POTEAT
Correspondent
OXLIFE LLC
141 TWIN SPRINGS RD.
HENDERSONVILLE,  NC  28792
Correspondent Contact MARGARET K POTEAT
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/11/2008
Decision Date 04/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-