• 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 K122098
Device Name APPS-HEALTH01
Original Applicant
ANDON HEALTH CO., LTD
no. 3 jin ping street,ya an road,
nankai district
tianjin,  CN 300190
Original Contact yi liu
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
MNW  
Date Received07/16/2012
Decision Date 03/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-