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 Gastroscope And Accessories, Flexible/Rigid
510(k) Number K063847
Device Name FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
Applicant
Fujinon, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Fujinon, Inc.
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Codes
ITX   IYN   IYO  
Date Received12/27/2006
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-