Monarch Platform— 510(k) K193534
Substantially EquivalentAuris Health, Inc.
FDA 510(k) clearance K193534 for Monarch Platform, Substantially Equivalent on 2020-04-15. Applicant: Auris Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Auris Health, Inc.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood, CA, US
Recent devices under product code EOQ
view allMore clearances from Auris Health, Inc.
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193534
K-number listed on FDA's recall record- Z-1383-2026 — MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
- Z-0448-2024 — Monarch Platform REF MON-000005-01, 100-240V- 50/60Hz 1440w
- Z-0449-2024 — Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
- Z-0450-2024 — Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193534.
Data sourced from openFDA. This site is unofficial and independent of the FDA.