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 Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K201098
Device Name Ambu Duodeno System
Applicant
Ambu Innovation GmbH
Peterhofstr 3b
Kissing,  DE 86438
Applicant Contact Oliver V Ruepprecht
Correspondent
Ambu Inc.
6230 Old Dobbin Lane Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
FET  
Date Received04/24/2020
Decision Date 07/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-