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 K043217
Device Name A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR
Applicant
A&D Engineering, Inc.
1555 Mccandless Dr.
Milpitas,  CA  95035
Applicant Contact JERRY WANG
Correspondent
A&D Engineering, Inc.
1555 Mccandless Dr.
Milpitas,  CA  95035
Correspondent Contact JERRY WANG
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/22/2004
Decision Date 03/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-