• 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 K011058
Device Name TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII
Applicant
MERIDIAN MEDICAL TECHNOLOGIES LTD.
207 AIRPORT RD., WEST
BELFAST,  IE BT3 9ED
Applicant Contact RHONA LOVE
Correspondent
MERIDIAN MEDICAL TECHNOLOGIES LTD.
207 AIRPORT RD., WEST
BELFAST,  IE BT3 9ED
Correspondent Contact RHONA LOVE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/06/2001
Decision Date 10/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-