K260382
- 510(k) number
- K260382
- Device name
- MONARCH Platform (MON-000008)
- Applicant
- Auris Health, Inc. CA · US
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2026-07-25
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K260382.pdf
Official FDA record: K260382
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.