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 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K203749
Device Name Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Karina Matthiesen
Correspondent
Ambu, Inc.
6230 Old Dobbin Ln. Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number868.5740
Classification Product Code
CBI  
Date Received12/23/2020
Decision Date 05/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-