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, Imaging, Gastrointestinal, Wireless, Capsule
510(k) Number K032405
Device Name GIVEN DIAGNOSTIC SYSTEM
Applicant
Given Imaging , Ltd.
13 Hayetzira St.
New Industrial Zone
Yokneam,  IL 20692
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Given Imaging , Ltd.
13 Hayetzira St.
New Industrial Zone
Yokneam,  IL 20692
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received08/04/2003
Decision Date 10/29/2003
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
-
-