510(k) K243219 · EOQ Bronchoscope (Flexible Or Rigid)
MONARCH Platform (MON-000008)
| Applicant | Auris Health, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jan 23, 2025 |
| Received | Oct 7, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243219
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2026 | Auris Health, Inc MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.