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 K072688
Device Name LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
Applicant
INTERNATIONAL BIOPHYSICS CORP.
2101-2 E. ST. ELMO
SUITE 275
AUSTIN,  TX  78744
Applicant Contact DAVID SHOCKLEY
Correspondent
INTERNATIONAL BIOPHYSICS CORP.
2101-2 E. ST. ELMO
SUITE 275
AUSTIN,  TX  78744
Correspondent Contact DAVID SHOCKLEY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/24/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-