Monarch Platform— 510(k) K193534

Substantially Equivalent

Auris Health, Inc.

FDA 510(k) clearance K193534 for Monarch Platform, Substantially Equivalent on 2020-04-15. Applicant: Auris Health, Inc..

Clearance details

Applicant: Auris Health, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2019-12-20
Decision date: 2020-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.