510(k) K193534 ยท EOQ Bronchoscope (Flexible Or Rigid)
Monarch Platform
| Applicant | Auris Health, Inc., Redwood CA, US |
| Decision | Substantially Equivalent, Apr 15, 2020 |
| Received | Dec 20, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193534
| 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 |
| Dec 1, 2023 | AURIS HEALTH INC Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w Open, Classified |
EOQ | None listed |
| Dec 1, 2023 | AURIS HEALTH INC Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w Open, Classified |
EOQ | None listed |
| Dec 1, 2023 | AURIS HEALTH INC Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w Open, Classified |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.