510(k) Premarket Notification

• 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 Lane, Suite 250; Columbia, MD 21045
• Correspondent Contact: Sanjay Parikh
• Regulation Number: 874.4680
• Classification Product Code: EOQ
• Date Received: 10/27/2022
• 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
• Recalls: CDRH Recalls