• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K102690
Model KD558
Device Name FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Original Applicant
ANDON HEALTH CO.,LTD
no 3, jinping street ya an rd
nankai district
tianjin,  CH 300190
Original Contact liu yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/17/2010
Decision Date 11/24/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Special
Clinical Trials NCT00723814
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-