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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 K233671
Device Name Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Lasse Sohrt-Petersen
Correspondent
Ambu, Inc.
6721 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact Sanjay Parikh
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received11/15/2023
Decision Date 01/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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