K173603

Substantially Equivalent

Monarch Airway Clearance System

Applicant: Hill-Rom Holdings, Inc.
Product code: BYI
Advisory panel: Anesthesiology
Date received: 2017-11-21
Decision date: 2018-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.