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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Karina Matthiesen
Ambu Inc.
6230 Old Dobbin Lane, Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number868.5740
Classification Product Code
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
Recalls CDRH Recalls