510(k) Premarket Notification

• Device Classification Name: bronchoscope (flexible or rigid)
• 510(k) Number: K130845
• Device Name: AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW
• Applicant: AMBU A/S; 6740 BAYMEADOW DR.; GLEN BURNIE, MD 21060
• Applicant Contact: SANJAY PARIKH
• Correspondent: AMBU A/S; 6740 BAYMEADOW DR.; GLEN BURNIE, MD 21060
• Correspondent Contact: SANJAY PARIKH
• Regulation Number: 874.4680
• Classification Product Code: EOQ
• Date Received: 03/26/2013
• Decision Date: 11/01/2013
• 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