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 K171833
Device Name Digital Blood Pressure Monitor-Wrist Style
Applicant
Shenzhen Combei Technology Co., Ltd.
Floor 5, Block B, Bldg. G, Jinxiongda Science Park,
Soth Huanguan Rd.
Guanlan, Shenzhen,  CN 518110
Applicant Contact Huaguang Meng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1122#, Internation Mayor Communication Center,
Baishizhong Rd. 55#,
Nanshan District, Shenzhen,  CN 518000
Correspondent Contact Migo Yang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/19/2017
Decision Date 01/10/2018
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
-
-