• 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 K083559
Device Name YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
Applicant
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/02/2008
Decision Date 09/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-