Monarch Platform
FDA 510(k) clearance K193534 · decided 2020-04-15
Clearance details
- K-number
- K193534
- Device name
- Monarch Platform
- Applicant
- Auris Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-12-20
- Decision date
- 2020-04-15
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Redwood, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-0000 recall (Z-1383-2026) | Auris Health, Inc | 2026-02-17 |
| Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w recall (Z-0448-2024) | AURIS HEALTH INC | 2023-12-01 |
| Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w recall (Z-0449-2024) | AURIS HEALTH INC | 2023-12-01 |
| Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w recall (Z-0450-2024) | AURIS HEALTH INC | 2023-12-01 |