510(k) K211493 ยท EOQ Bronchoscope (Flexible Or Rigid)
Monarch Platform
| Applicant | Auris Health, Inc., Redwood CA, US |
| Decision | Substantially Equivalent, Jul 9, 2021 |
| Received | May 13, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211493
| 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 |
| Oct 10, 2024 | AURIS HEALTH INC Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R.
Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB. Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.