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 K191253
Device Name Reusable NIBP Cuff
Applicant
Shenzhen Changke Connect Electronics Co., Ltd.
A2-4th Floor Of Xiang Dali Technology Park
#87 Of Hengping Rd., Henggang
Longgang District, Shenzhen,  CN
Applicant Contact Yahui Zhou
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
# A415, Block A, Nanshan Medical Devices Industrial Park
Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received05/09/2019
Decision Date 09/17/2019
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
-
-