• 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 K150311
Device Name Full Automatic (NIBP)Blood Pressure Monitor
Applicant
Health & Life Co., Ltd.
9f, no. 186, jian yi road
zhonghe district, new taipei city,  TW 23553
Applicant Contact sarah su
Correspondent
Health & Life Co., Ltd.
9f, no. 186, jian yi road
zhonghe district, new taipei city,  TW 23553
Correspondent Contact sarah su
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/09/2015
Decision Date 08/18/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-