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 Image Management Software For Planning Of Otologic And Neurotologic Procedures
510(k) Number K220300
Device Name OTOPLAN
Applicant
Cascination AG
Steigerhubelstrasse 3
Bern,  CH 3008
Applicant Contact Jean-Francois Clemence
Correspondent
Cascination AG
Steigerhubelstrasse 3
Bern,  CH 3008
Correspondent Contact Jean-Francois Clemence
Regulation Number892.2050
Classification Product Code
QQE  
Date Received02/02/2022
Decision Date 06/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-