K243219
- 510(k) number
- K243219
- Device name
- MONARCH Platform (MON-000008)
- Applicant
- Auris Health, Inc. CA · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2025-01-23
- Date received
- 2024-10-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243219.pdf
Official FDA record: K243219
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.