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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K223299
FOIA Releasable 510(k) K223299
Device Name Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Magnus Lynge
Correspondent
Ambu, Inc.
6230 Old Dobbin Ln. Suite 250
Columbia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/27/2022
Decision Date 06/01/2023
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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