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, Gastrointestinal Motility (Electrical)
510(k) Number K062222
Device Name UNITIP HIGH RESOLUTION CATHETER
Applicant
UNISENSOR AG
13605 WEST 7TH AVE.
GOLDEN,  CO  80401 -4604
Applicant Contact ROBERT N CLARK
Correspondent
UNISENSOR AG
13605 WEST 7TH AVE.
GOLDEN,  CO  80401 -4604
Correspondent Contact ROBERT N CLARK
Regulation Number876.1725
Classification Product Code
FFX  
Date Received08/02/2006
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-