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 endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K032545
Device Name ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
Applicant
MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
SCHWARZSCHILDSTRASSE 6
BERLIN,  DE 12489
Applicant Contact JOHANNES TSCHEPE
Correspondent
TUV AMERICA, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number876.1500
Classification Product Code
FET  
Date Received08/18/2003
Decision Date 09/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-