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 bronchoscope (flexible or rigid)
510(k) Number K121035
Device Name FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
Applicant
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
10 HIGH POINT DRIVE
WAYNE,  NJ  07470
Applicant Contact GINA WALLJASPER
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
ITX  
Date Received04/05/2012
Decision Date 06/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-