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 system, measurement, blood-pressure, non-invasive
510(k) Number K152003
Device Name iHealth BP3L Wireless Blood Pressure Monitor
Applicant
ANDON HEALTH CO.,LTD
NO 3, JINPING STREET, YA AN ROAD
NANKAI DISTRICT
tianjin,  CN 300190
Applicant Contact liu yi
Correspondent
ANDON HEALTH CO.,LTD
NO 3, JINPING STREET, YA AN ROAD
NANKAI DISTRICT
tianjin,  CN 300190
Correspondent Contact liu yi
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/20/2015
Decision Date 09/24/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-