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 Blood Pressure Cuff
510(k) Number K151810
Device Name Bpump Blood Pressure Cuff
Applicant
Shenzhen Pump Medical System Co., Ltd.
2/F, M-7 Sinosteel Bldg., Maqueling Estate,
Hi-Tech Industrial Park
Nanshan District, Shenzhen,  CN 518057
Applicant Contact XIE QIONGYU
Correspondent
Shenzhen Pump Medical System Co., Ltd.
2/F, M-7 Sinosteel Bldg., Maqueling Estate,
Hi-Tech Industrial Park
Nanshan District, Shenzhen,  CN 518057
Correspondent Contact MIGO YANG
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received07/02/2015
Decision Date 12/17/2015
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
-
-