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 K183419
Device Name EVIS EXERA III Bronchovideoscope Olympus BF-XT190
Applicant
Olympus Medical Systems Corp.
2951 Ishikawa-cho
Hachioji-Shi,  JP 192-8507
Applicant Contact Toshiyuki Nakajima
Correspondent
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact Sheri L. Musgnung
Regulation Number874.4680
Classification Product Code
EOQ  
Subsequent Product Code
EOB  
Date Received12/10/2018
Decision Date 09/05/2019
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
Recalls CDRH Recalls
-
-