• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name generator, oxygen, portable
510(k) Number K121531
Device Name A&J 5L POCA SERIES OXYGEN CONCENTRATOR
Original Applicant
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.
3 shenghui south road
nantou town, zhongshan city
guangdong,  CN
Original Contact junhong an
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/24/2012
Decision Date 07/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-