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 K031662
Device Name PRESSURE WIRE SENSOR, MODELS 12004/12304
Applicant
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Applicant Contact MATS GRANLUND
Correspondent
Radi Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE S-754 50
Correspondent Contact MATS GRANLUND
Regulation Number870.2870
Classification Product Code
DXO  
Date Received05/28/2003
Decision Date 06/06/2003
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
-
-