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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 K173727
Device Name Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
Applicant
Ambu A/S
Baltorpbakken 13
Ballerup,  DK 2750
Applicant Contact Maja Brons
Correspondent
Ambu Inc.
6230 Old Dobbin Lane
Suite 250
Colombia,  MD  21045
Correspondent Contact Sanjay Parikh
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/05/2017
Decision Date 03/28/2018
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
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