K232582
- 510(k) number
- K232582
- Device name
- Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set
- Applicant
- Ambu A/S DK
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2023-09-20
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232582.pdf
Official FDA record: K232582
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.