K233671

Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance

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 DK
Product code
EOQ — Bronchoscope (Flexible Or Rigid)
Decision date
2024-01-04
Date received
2023-11-15
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K233671.pdf

Official FDA record: K233671
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.