K231473
- 510(k) number
- K231473
- Device name
- Monarch Bronchoscope
- Applicant
- Auris Health, Inc., A Johnson and Johnson Family Company CA · US
- Product code
- QNW — Reprocessed Bronchoscope
- Decision date
- 2023-11-28
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231473.pdf
Official FDA record: K231473
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.