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 K200649
Device Name Arm-Type Fully Automatic Digital Blood Pressure Monitor
Applicant
Joytech Healthcare Co., Ltd
No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou City
Hangzhou,  CN 311100
Applicant Contact Ren Yunhua
Correspondent
Joytech Healthcare Co., Ltd
No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou City
Hangzhou,  CN 311100
Correspondent Contact Ren Yunhua
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/12/2020
Decision Date 08/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-