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 K134029
Device Name BELTER BLOOD PRESSURE METER
Applicant
Shenzhen Belter Health Measurement and Analysis TE
702, 704 Block C, Tsinghua Unis Science Park
# 13 Langshan Rd. Hi-Tech Ind
Shenzhen, Guangdong,  CN 518057
Applicant Contact PANG MING
Correspondent
Shenzhen Belter Health Measurement and Analysis TE
702, 704 Block C, Tsinghua Unis Science Park
# 13 Langshan Rd. Hi-Tech Ind
Shenzhen, Guangdong,  CN 518057
Correspondent Contact PANG MING
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/31/2013
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-