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 Transducer, Pressure, Catheter Tip
510(k) Number K062769
Device Name PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
Applicant
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE SE-754 50
Applicant Contact MATS GRANLUND
Correspondent
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE SE-754 50
Correspondent Contact MATS GRANLUND
Regulation Number870.2870
Classification Product Code
DXO  
Subsequent Product Code
DQX  
Date Received09/15/2006
Decision Date 12/04/2006
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
-
-