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 K040229
Device Name A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
Applicant
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS,  CA  95035
Applicant Contact JERRY WANG
Correspondent
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS,  CA  95035
Correspondent Contact JERRY WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/02/2004
Decision Date 03/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-