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 K070473
Device Name BLOOD PRESSURE MONITOR, MODELS ZSBP-OXX AND ZSBP-1XX
Applicant
Zen Strong Medical Technology Co., Ltd.
6f,#88 Ning Jing St.,
Keelung,,  TW
Applicant Contact CHENG ROEI-SHENG
Correspondent
Zen Strong Medical Technology Co., Ltd.
6f,#88 Ning Jing St.,
Keelung,,  TW
Correspondent Contact CHENG ROEI-SHENG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/20/2007
Decision Date 05/23/2007
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
-
-