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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 K230428
Device Name Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Karina Matthiesen
Correspondent
Ambu, Inc.
6721 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received02/17/2023
Decision Date 08/10/2023
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
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