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 Ultrasound System, Gastroenterology-Urology
510(k) Number K042140
Device Name OLYMPUS BF TYPE UC160-OL8
Applicant
OLYMPUS CORPORATION
TWO CORPORATE CENTER DRIVE
MELVILLE,  NY  11747 -3157
Applicant Contact TINA STEFFANIE-OAK
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DERWYN REUBER
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
EOQ   FDS   ITX  
Date Received08/09/2004
Decision Date 08/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
-
-