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 K171291
Device Name FUJIFILM Bronchoscope Model EB-530P
Applicant
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Applicant Contact Shraddha S. More
Correspondent
FUJIFILM Medical Systems U.S.A., Inc.
10 High Point Drive
Wayne,  NJ  07470
Correspondent Contact Shraddha S. More
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received05/02/2017
Decision Date 01/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-